(a) Identification. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in Sec. 868.9. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001]