Code of Federal Regulations · Section
§ 868.5925 — Powered Emergency Ventilator
21 C.F.R. § 868.5925
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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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351