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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device isocapnic ventilation device
Definition An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).
Product CodeQFB
Regulation Number 868.5480
Device Class 2


Premarket Reviews
ManufacturerDecision
THORNHILL RESEARCH, INC.
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