21 C.F.R. § 868.5350 Nasal oxygen catheter.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5350 Nasal oxygen catheter.