Mobile Operating Table 1132.01
FDA 510(k) K970807 · Stierlen-Maquet AG
510(k) numberK970807
Submission
- Device name
- Mobile Operating Table 1132.01
- Applicant
- Stierlen-Maquet AG
Rastatt, DE - Received
- March 5, 1997
- Decision date
- March 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- GDC – Table, Operating-Room, Electrical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971390 | Quantum 3080SP Surgical TableGDC · Traditional | STERIS Corporation | 05/15/1997SE |
| K964273 | Dura-Board ArmboardGDC · Traditional | Allen Medical Systems, Inc. | 01/08/1997SE |
| K940616 | Skytron Elite 3500 TableGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 06/13/1994SE |
| K934744 | Midmark Magnum General Surgical TableGDC · Traditional | Midmark Corp. | 03/28/1994SE |
| K914758 | Mdt/Shampaine Model 4900B Surgical TableGDC · Traditional | Mdt Corp., Inc. | 12/19/1991SE |
| K915393 | Mdt/Shampaine Model 4900E Surgical TableGDC · Traditional | Mdt Corp., Inc. | 12/17/1991SE |
| K883613 | Oper. Table for Percutan. Trans. Coronary Angio.GDC · Traditional | Stierlen-Maquet AG | 09/15/1988SE |
| K853720 | Mobile Operating Table for Orl MicrosurgeryGDC · Traditional | Carl Zeiss, Inc. | 10/18/1985SE |
| K853480 | Skytron Elite 6000 & 6001 Surgical TablesGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 09/12/1985SE |
| K853535 | Trauma TableGDC · Traditional | Xre Corp. | 09/11/1985SE |
More from Xre Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K926525 | Betastar 1131.02 Mobile Operating TableFQO · Traditional | 10/12/1993SE |
| K920890 | Operating Table System-Betamaquet 1140FQO · Traditional | 07/02/1992SE |
| K883613 | Oper. Table for Percutan. Trans. Coronary Angio.GDC · Traditional | 09/15/1988SE |
| K873276 | Extension Device 1416JEB · Traditional | 09/17/1987SE |
| K873275 | Extension Table 1417JEB · Traditional | 09/17/1987SE |
| K873274 | Plaster Table 1418JEB · Traditional | 09/17/1987SE |
| K873273 | Orthopaedic Table 1420JEB · Traditional | 09/17/1987SE |
| K873272 | Endoscopy Table 1532 EndostarBWN · Traditional | 09/08/1987SE |
| K843134 | Mobile Operating Table Heidelbergs 1130GDC · Traditional | 09/07/1984SE |
Questions and answers
When was Mobile Operating Table 1132.01 cleared by the FDA?
Mobile Operating Table 1132.01 (K970807) received a 510(k) decision of Substantially Equivalent on March 14, 1997, 9 days after the submission was received.
What is the product code of K970807?
The FDA product code is GDC – Table, Operating-Room, Electrical, a Class I (low risk) device regulated under 21 CFR 878.4960.