FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KERMATH L/C ARM
K Number: K812332
·
Decision Sep 16, 1981
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- KERMATH L/C ARM
- K Number
- K812332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Kermath Mfg. Corp.
- Date Received
- August 18, 1981
- Decision Date
- September 16, 1981
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Kermath Mfg. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K870221 | T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) | May 12, 1987 | Substantially Equivalent |
| K812726 | KERMATH THERAPY SIMULATOR | Nov 5, 1981 | Substantially Equivalent |
| K811215 | KERMATH RADIOGRAPHIC HEAD STAND | Jun 12, 1981 | Substantially Equivalent |
| K771549 | VERSATOME | Aug 25, 1977 | Substantially Equivalent |