External negative pressure ventilator.

21 C.F.R. § 868.5935
in effectEffective: 2024-07-01
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(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).

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