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.

Code of Federal Regulations

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

CFR

868.5110—Oropharyngeal airway.

Code of Federal Regulations