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