FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
MOBILE OPERATING TABLE 1132.01
K Number: K970807
·
Decision Mar 14, 1997
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
17
Applicant Total
10
Review Days
9
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Basic Information
- Device Name
- MOBILE OPERATING TABLE 1132.01
- K Number
- K970807
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stierlen-Maquet AG
- Date Received
- March 5, 1997
- Decision Date
- March 14, 1997
- Product Code
- GDC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Stierlen-Maquet AG
| K Number | Device Name | ||
|---|---|---|---|
| K926525 | BETASTAR 1131.02 MOBILE OPERATING TABLE | Oct 12, 1993 | Substantially Equivalent |
| K920890 | OPERATING TABLE SYSTEM-BETAMAQUET 1140 | Jul 2, 1992 | Substantially Equivalent |
| K883613 | OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. | Sep 15, 1988 | Substantially Equivalent |
| K873275 | EXTENSION TABLE 1417 | Sep 17, 1987 | Substantially Equivalent |
| K873273 | ORTHOPAEDIC TABLE 1420 | Sep 17, 1987 | Substantially Equivalent |
| K873276 | EXTENSION DEVICE 1416 | Sep 17, 1987 | Substantially Equivalent |
| K873274 | PLASTER TABLE 1418 | Sep 17, 1987 | Substantially Equivalent |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Sep 8, 1987 | Substantially Equivalent |
| K843134 | MOBILE OPERATING TABLE HEIDELBERGS 1130 | Sep 7, 1984 | Substantially Equivalent |