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Section 868.1
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Effective dates of requirement for premarket approval |
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Section 868.3
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) |
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Section 868.9
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Manual algesimeter |
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Section 868.1030
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Powered algesimeter |
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Section 868.1040
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Argon gas analyzer |
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Section 868.1075
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Arterial blood sampling kit |
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Section 868.1100
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Indwelling blood oxyhemoglobin concentration analyzer |
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Section 868.1120
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Indwelling blood carbon dioxide partial pressure (PCO2) analyzer |
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Section 868.1150
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Indwelling blood hydrogen ion concentration (pH) analyzer |
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Section 868.1170
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Indwelling blood oxygen partial pressure (PO2) analyzer |
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Section 868.1200
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Carbon dioxide gas analyzer |
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Section 868.1400
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Carbon monoxide gas analyzer |
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Section 868.1430
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Enflurane gas analyzer |
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Section 868.1500
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Gas collection vessel |
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Section 868.1575
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Halothane gas analyzer |
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Section 868.1620
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Helium gas analyzer |
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Section 868.1640
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Neon gas analyzer |
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Section 868.1670
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Nitrogen gas analyzer |
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Section 868.1690
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Nitrous oxide gas analyzer |
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Section 868.1700
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Oxygen gas analyzer |
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Section 868.1720
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Oxygen uptake computer |
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Section 868.1730
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Pressure plethysmograph |
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Section 868.1750
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Volume plethysmograph |
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Section 868.1760
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Inspiratory airway pressure meter |
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Section 868.1780
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Rhinoanemometer |
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Section 868.1800
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Diagnostic spirometer |
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Section 868.1840
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Monitoring spirometer |
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Section 868.1850
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Peak-flow meter for spirometry |
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Section 868.1860
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Gas volume calibrator |
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Section 868.1870
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Pulmonary-function data calculator |
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Section 868.1880
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Predictive pulmonary-function value calculator |
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Section 868.1890
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Diagnostic pulmonary-function interpretation calculator |
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Section 868.1900
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Esophageal stethoscope |
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Section 868.1910
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Esophageal stethoscope with electrical conductors |
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Section 868.1920
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Stethoscope head |
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Section 868.1930
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Switching valve (ploss) |
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Section 868.1965
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Water vapor analyzer |
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Section 868.1975
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Ultrasonic air embolism monitor |
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Section 868.2025
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Bourdon gauge flowmeter |
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Section 868.2300
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Uncompensated thorpe tube flowmeter |
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Section 868.2320
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Compensated thorpe tube flowmeter |
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Section 868.2340
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Gas calibration flowmeter |
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Section 868.2350
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Breathing frequency monitor |
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Section 868.2375
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Apnea monitor |
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Section 868.2377
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Nitric oxide analyzer |
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Section 868.2380
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Nitrogen dioxide analyzer |
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Section 868.2385
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Lung water monitor |
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Section 868.2450
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Cutaneous carbon dioxide (PcCO2) monitor |
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Section 868.2480
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Cutaneous oxygen (PcO2) monitor |
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Section 868.2500
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Pneumotachometer |
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Section 868.2550
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Airway pressure monitor |
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Section 868.2600
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Gas pressure gauge |
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Section 868.2610
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Gas pressure calibrator |
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Section 868.2620
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Pressure regulator |
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Section 868.2700
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Electrical peripheral nerve stimulator |
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Section 868.2775
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Differential pressure transducer |
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Section 868.2875
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Gas flow transducer |
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Section 868.2885
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Gas pressure transducer |
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Section 868.2900
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Emergency airway needle |
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Section 868.5090
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Nasopharyngeal airway |
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Section 868.5100
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Oropharyngeal airway |
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Section 868.5110
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Device to relieve acute upper airway obstruction |
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Section 868.5115
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Anesthesia conduction catheter |
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Section 868.5120
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Anesthesia conduction filter |
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Section 868.5130
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Anesthesia conduction kit |
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Section 868.5140
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Anesthesia conduction needle |
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Section 868.5150
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Gas machine for anesthesia or analgesia |
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Section 868.5160
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Nitric oxide administration apparatus |
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Section 868.5165
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Laryngotracheal topical anesthesia applicator |
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Section 868.5170
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Rocking bed |
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Section 868.5180
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Blow bottle |
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Section 868.5220
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Anesthesia breathing circuit |
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Section 868.5240
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Breathing circuit circulator |
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Section 868.5250
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Breathing circuit bacterial filter |
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Section 868.5260
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Breathing system heater |
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Section 868.5270
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Breathing tube support |
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Section 868.5280
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Carbon dioxide absorbent |
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Section 868.5300
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Carbon dioxide absorber |
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Section 868.5310
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Reservoir bag |
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Section 868.5320
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Breathing gas mixer |
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Section 868.5330
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Nasal oxygen cannula |
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Section 868.5340
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Nasal oxygen catheter |
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Section 868.5350
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Posture chair for cardiac or pulmonary treatment |
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Section 868.5365
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Heat and moisture condenser (artificial nose) |
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Section 868.5375
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Electroanesthesia apparatus |
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Section 868.5400
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Ether hook |
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Section 868.5420
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Gas-scavenging apparatus |
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Section 868.5430
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Portable oxygen generator |
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Section 868.5440
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Respiratory gas humidifier |
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Section 868.5450
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Therapeutic humidifier for home use |
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Section 868.5460
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Hyperbaric chamber |
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Section 868.5470
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Flexible laryngoscope |
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Section 868.5530
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Rigid laryngoscope |
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Section 868.5540
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Anesthetic gas mask |
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Section 868.5550
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Gas mask head strap |
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Section 868.5560
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Nonrebreathing mask |
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Section 868.5570
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Oxygen mask |
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Section 868.5580
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Scavenging mask |
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Section 868.5590
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Venturi mask |
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Section 868.5600
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Membrane lung for long-term pulmonary support |
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Section 868.5610
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Breathing mouthpiece |
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Section 868.5620
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Nebulizer |
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Section 868.5630
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Medicinal nonventilatory nebulizer (atomizer) |
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Section 868.5640
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Esophageal obturator |
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Section 868.5650
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Portable liquid oxygen unit |
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Section 868.5655
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Powered percussor |
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Section 868.5665
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Rebreathing device |
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Section 868.5675
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Incentive spirometer |
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Section 868.5690
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Nonpowered oxygen tent |
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Section 868.5700
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Electrically powered oxygen tent |
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Section 868.5710
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Bronchial tube |
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Section 868.5720
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Tracheal tube |
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Section 868.5730
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Tracheal/bronchial differential ventilation tube |
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Section 868.5740
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Inflatable tracheal tube cuff |
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Section 868.5750
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Cuff spreader |
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Section 868.5760
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Tracheal tube fixation device |
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Section 868.5770
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Tube introduction forceps |
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Section 868.5780
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Tracheal tube stylet |
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Section 868.5790
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Tracheal tube cleaning brush |
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Section 868.5795
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Tracheostomy tube and tube cuff |
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Section 868.5800
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Airway connector |
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Section 868.5810
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Dental protector |
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Section 868.5820
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Autotransfusion apparatus |
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Section 868.5830
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Pressure tubing and accessories |
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Section 868.5860
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Nonrebreathing valve |
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Section 868.5870
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Anesthetic vaporizer |
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Section 868.5880
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Continuous ventilator |
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Section 868.5895
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Noncontinuous ventilator (IPPB) |
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Section 868.5905
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Manual emergency ventilator |
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Section 868.5915
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Powered emergency ventilator |
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Section 868.5925
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External negative pressure ventilator |
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Section 868.5935
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Intermittent mandatory ventilation attachment |
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Section 868.5955
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Positive end expiratory pressure breathing attachment |
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Section 868.5965
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Ventilator tubing |
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Section 868.5975
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Tee drain (water trap) |
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Section 868.5995
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Anesthetic cabinet, table, or tray |
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Section 868.6100
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Cardiopulmonary emergency cart |
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Section 868.6175
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Nose clip |
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Section 868.6225
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Portable air compressor |
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Section 868.6250
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Calibration gas |
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Section 868.6400
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Anesthesia stool |
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Section 868.6700
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Tracheobronchial suction catheter |
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Section 868.6810
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Patient position support |
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Section 868.6820
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Medical gas yoke assembly |
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Section 868.6885
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Scope |