FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
ClearMate
K Number: DEN170044
·
Decision Mar 14, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
5
Review Days
573
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Basic Information
- Device Name
- ClearMate
- K Number
- DEN170044
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 868.5480
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Thornhill Research, Inc.
- Date Received
- August 18, 2017
- Decision Date
- March 14, 2019
- Product Code
- QFB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFB | Isocapnic Ventilation Device | FDA class 2 | General Hospital |