FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLEAR-TEMP
K Number: K926030
·
Decision Feb 24, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
32
Review Days
450
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Basic Information
- Device Name
- KLEAR-TEMP
- K Number
- K926030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cas Medical Systems, Inc.
- Date Received
- December 1, 1992
- Decision Date
- February 24, 1994
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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