510(k) DEN170044
DEN170044 is an FDA 510(k) premarket notification submitted by Thornhill Research, Inc. for the device "ClearMate". The FDA issued a decision of De Novo Granted on March 14, 2019. The device falls under product code QFB (Isocapnic Ventilation Device), a Class II device regulated under 21 CFR 868.5480. Thornhill Research, Inc. has at least 4 other 510(k) clearances on record.
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).