FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
K Number: K960224
·
Decision Mar 25, 1996
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
32
Applicant Total
3
Review Days
68
Basic Information
- Device Name
- GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
- K Number
- K960224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- RG ENT., INC.
- Date Received
- January 17, 1996
- Decision Date
- March 25, 1996
- Product Code
- FLK
- 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 |
|---|---|---|---|
| FLK | Thermometer, Clinical Mercury | FDA class 2 | General Hospital |
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