21 CFR § 868.5935 Anesthesiology Devices

§ 868.5935 External negative pressure ventilator.

Current through Sep 8, 2026 · Read all of Part 868

(a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

(b) Classification. Class II (performance standards).

← § 868.5925 Powered emergency ventilator.§ 868.5955 Intermittent mandatory ventilation attachment. →