(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]