21 CFR 868.5470

§ 868.5470 Hyperbaric chamber.

United States · 21 CFR — Food and Drugs · Status: effective

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Citation: 21 CFR 868.5470, § 868.5470 Hyperbaric chamber, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89807
Permanent ID: ys:prov:89807@1
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Full text

(a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650). (b) Classification. Class II (performance standards).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.