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21 CFR 868.5925

§ 868.5925 Powered emergency ventilator.

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

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21 CFR 868.5925, § 868.5925 Powered emergency ventilator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89846
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(a) Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. (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.