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