21 C.F.R. § 868.5925
Powered emergency ventilator.
Cite as 21 C.F.R. § 868.5925 (2026)
(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).