21 C.F.R. § 868.5895

Current through April 30, 2024
Section 868.5895 - Continuous ventilator
(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