21 CFR § 868.5340
Nasal oxygen cannula
June 25, 2020
(a) Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.
(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.
[47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001]