CRITICOOL
FDA 510(k) clearance K083662 · decided 2009-03-26
Clearance details
- K-number
- K083662
- Device name
- CRITICOOL
- Applicant
- Mtre Advanced Technology , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-10
- Decision date
- 2009-03-26
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Yavne, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CritiCool, thermoregulation device recall (Z-0153-2023) | Belmont Instrument Corporation | 2022-10-31 |