21 CFR 868.5350
§ 868.5350 Nasal oxygen catheter.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.5350, § 868.5350 Nasal oxygen catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89797
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.