21 CFR § 868.5110 - Oropharyngeal airway.
§ 868.5110 Oropharyngeal airway.
(a) Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth 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.