e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 868 → Subpart F → §868.5350 |
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
(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]