21 C.F.R. § 868.5895

Continuous ventilator.

Last amended: 2016Year: 2026Length: 47 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.5895 (2026)

(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. (b) Classification. Class II (performance standards).
21 C.F.R. § 868.5895: Continuous ventilator. | Justis AI