Title 21

SECTION 868.5350

868.5350 Nasal oxygen catheter.

§ 868.5350 Nasal oxygen catheter.

(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]

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