FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPEX INC. ORAL AND RECTAL THERMOMETERS
K Number: K913793
·
Decision Dec 30, 1991
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
32
Applicant Total
5
Review Days
129
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Basic Information
- Device Name
- SIMPEX INC. ORAL AND RECTAL THERMOMETERS
- K Number
- K913793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Simpex, Inc.
- Date Received
- August 23, 1991
- Decision Date
- December 30, 1991
- 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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