21 C.F.R. § 868.5350
Nasal oxygen catheter.
Cite as 21 C.F.R. § 868.5350 (2026)
(a) Identification. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen. (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.