QFB · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 868.5480
Classification
FDA Product Code
QFB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5480
Review panel
AN
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).