FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
K Number: K100585
·
Decision Jan 20, 2011
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
27
Review Days
324
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Basic Information
- Device Name
- MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
- K Number
- K100585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gaymar Industries, Inc.
- Date Received
- March 2, 2010
- Decision Date
- January 20, 2011
- 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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