510(k) DEN170044
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 14, 2019
- Date Received
- August 18, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Isocapnic Ventilation Device
- Device Class
- Class II
- Regulation Number
- 868.5480
- Review Panel
- AN
- Submission Type
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).