StacksVerified U.S. regulatory reference

21 CFR §868.5915

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II (performance standards).