868.5975—Ventilator tubing.
(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 § 868.9.