21 CFR 868.5935
§ 868.5935 External negative pressure ventilator.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5935, § 868.5935 External negative pressure ventilator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89847
- Permanent ID
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.