Continuous ventilator.

21 C.F.R. § 868.5895
in effectEffective: 2024-07-01
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(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).

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