U.S. FDA Medical Device External Negative Pressure Ventilator Requirements: External Negative Pressure Ventilator
FDA Medical Device Definition: 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
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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