21 C.F.R. § 868.5110

Current through September 30, 2024
Section 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 .

21 C.F.R. §868.5110

47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001