Mobile Operating Table Heidelbergs 1130
FDA 510(k) K843134 · Stierlen-Maquet AG
510(k) numberK843134
Submission
- Device name
- Mobile Operating Table Heidelbergs 1130
- Applicant
- Stierlen-Maquet AG
Mchenry, IL, US - Received
- August 9, 1984
- Decision date
- September 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K970807 | Mobile Operating Table 1132.01GDC · Traditional | Stierlen-Maquet AG | 03/14/1997SE |
| 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 |
More from Skytron, Div. the Kmw Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970807 | Mobile Operating Table 1132.01GDC · Traditional | 03/14/1997SE |
| 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 |
Questions and answers
When was Mobile Operating Table Heidelbergs 1130 cleared by the FDA?
Mobile Operating Table Heidelbergs 1130 (K843134) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 29 days after the submission was received.
What is the product code of K843134?
The FDA product code is GDC – Table, Operating-Room, Electrical, a Class I (low risk) device regulated under 21 CFR 878.4960.