21 CFR § 868.5100 - Nasopharyngeal airway.
§ 868.5100 Nasopharyngeal airway.
(a) Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.
(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.