Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 868.5925 Powered emergency ventilator.
§ 868.5925 Powered emergency ventilator.
(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).