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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Isocapnic Ventilation Device

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5480

Medical specialty

General Hospital

FDA 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).

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