FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K Number: K071341
·
Decision Aug 3, 2007
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
12
Review Days
81
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Basic Information
- Device Name
- MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
- K Number
- K071341
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medivance, Inc.
- Date Received
- May 14, 2007
- Decision Date
- August 3, 2007
- 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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