Clearance Summary
ClearMate received FDA 510(k) clearance under submission number DEN170044, sponsored by Thornhill Research, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-03-14.
- Submission: DEN170044
- Applicant / Sponsor: Thornhill Research, Inc.
- Clearance pathway: Direct
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 868.5480
- Decision date: 2019-03-14
Classification & Regulation
This clearance is catalogued under FDA product code QFB and 21 CFR 868.5480, within the General Hospital review panel as a Class II device.