ClearMate
FDA 510(k) clearance DEN170044 · decided 2019-03-14
Clearance details
- K-number
- DEN170044
- Device name
- ClearMate
- Applicant
- Thornhill Research, Inc.
- Decision
- Unknown
- Date received
- 2017-08-18
- Decision date
- 2019-03-14
- Days to decision
- 573 days
- Clearance type
- Direct
- Product code
- QFB
- Device class
- 2
- Regulation number
- 868.5480
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.