21 CFR 868.5700
§ 868.5700 Nonpowered oxygen tent.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5700, § 868.5700 Nonpowered oxygen tent, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89825
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Full text
(a) Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.
(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 § 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.