510(k) DEN170044
- Device
- ClearMate
- Applicant
- Thornhill Research, Inc.
- 510(k) number
- DEN170044
- Product code
- QFB
- Decision
- Unknown (DENG)
- Decision date
- 2019-03-14
- Date received
- 2017-08-18
- Regulation
- 868.5480
- Classification name
- Isocapnic Ventilation Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kipton Lade
- Address
- 210 Dundas St. W. Toronto CA M5G 2E8 M5G 2E8
FDA Registration Numbers#
- 3005803793
Source Documents#
510(k) summary PDF not indicated by FDA