FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CRITICOOL PRO
K Number: K102112
·
Decision Nov 18, 2010
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
6
Review Days
113
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Basic Information
- Device Name
- CRITICOOL PRO
- K Number
- K102112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mtre Advanced Technology , Ltd.
- Date Received
- July 28, 2010
- Decision Date
- November 18, 2010
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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Other Clearances by Mtre Advanced Technology , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K083662 | CRITICOOL | Mar 26, 2009 | Substantially Equivalent |
| K024128 | ALLON 2001 VERSION 5 | Feb 10, 2003 | Substantially Equivalent |
| K003349 | ALLON 2001 MODIFIED | Nov 13, 2000 | Substantially Equivalent |
| K001546 | ALLON 2001 | Jun 8, 2000 | Substantially Equivalent |
| K992386 | ALLON 2000 | Mar 7, 2000 | Substantially Equivalent |