Isocapnic Ventilation Device
The Isocapnic Ventilation Device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation while maintaining stable carbon dioxide levels, and may be labeled for use with breathing circuits including reservoir bags, oxygen cannulas, masks, valves, resuscitation bags, and/or tubing. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 868.5480 in the General Hospital specialty. The product code is QFB. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFB
- Device Class
- FDA class 2
- Regulation Number
- 868.5480
- Medical Specialty
- General Hospital
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170044 | ClearMate | Mar 14, 2019 | Unknown | Thornhill Research, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.