Betastar 1131.02 Mobile Operating Table
FDA 510(k) K926525 · Stierlen-Maquet AG
510(k) numberK926525
Submission
- Device name
- Betastar 1131.02 Mobile Operating Table
- Applicant
- Stierlen-Maquet AG
West-Germany, DE - Received
- December 30, 1992
- Decision date
- October 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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| K963506 | Tenet Radiolucent Hand TableFQO · Traditional | Tenet Medical Engineering | 01/09/1997SE |
| K961886 | Drager Gemina Wall-Mounted WorkplaceFQO · Traditional | Alm Surgical Equipment, Inc. | 07/30/1996SE |
| K961742 | Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional | Alm Surgical Equipment, Inc. | 07/26/1996SE |
| K955750 | TeletomFQO · Traditional | Berchtold Holding GmbH | 02/08/1996SE |
More from Berchtold Holding GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K970807 | Mobile Operating Table 1132.01GDC · Traditional | 03/14/1997SE |
| 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 Betastar 1131.02 Mobile Operating Table cleared by the FDA?
Betastar 1131.02 Mobile Operating Table (K926525) received a 510(k) decision of Substantially Equivalent on October 12, 1993, 286 days after the submission was received.
What is the product code of K926525?
The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.