QFB — Isocapnic Ventilation Device Class II
FDA product code QFB covers "Isocapnic Ventilation Device", a Class II medical device regulated under 21 CFR 868.5480. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QFB
- Device Class
- Class II
- Regulation Number
- 868.5480
- Submission Type
- Review Panel
- AN
- Medical Specialty
- General Hospital
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170044 | thornhill research | ClearMate | March 14, 2019 |