21 CFR § 868.5810 - Airway connector.
§ 868.5810 Airway connector.
(a) Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
(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.