21 CFR § 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.