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Electronic Code of Federal Regulations

e-CFR data is current as of April 8, 2020

Title 21Chapter ISubchapter HPart 868Subpart F → §868.5935


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices


§868.5935   External negative pressure ventilator.

(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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