21 C.F.R. § 868.5340

Nasal oxygen cannula.

Last amended: 2016Year: 2026Length: 72 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.5340 (2026)

(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]
Cross-references to the CFR
868.9.
21 C.F.R. § 868.5340: Nasal oxygen cannula. | Justis AI