21 C.F.R. § 868.5915

Manual emergency ventilator.

Last amended: 2016Year: 2026Length: 41 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.5915 (2026)

(a) Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).
21 C.F.R. § 868.5915: Manual emergency ventilator. | Justis AI