QFB

Isocapnic Ventilation Device

Product code

QFB

Device name

Isocapnic Ventilation Device

Device class

Class 2

21 CFR

21 CFR 868.5480

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).