Manual emergency ventilator.
21 C.F.R. § 868.5915
in effectEffective: 2024-07-01(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).
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
