Quantum 3080 Surgical Table
FDA 510(k) K930493 · American Sterilizer Co.
510(k) numberK930493
Submission
- Device name
- Quantum 3080 Surgical Table
- Applicant
- American Sterilizer Co.
Erie, PA, US - Received
- February 1, 1993
- Decision date
- June 22, 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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|---|---|---|---|
| K240598 | Maestro System (REF100)FQO · Traditional | Moon Surgical | 06/03/2024SE |
| K221410 | Maestro PlatformFQO · Traditional | Moon Surgical | 12/02/2022SE |
| K090136 | Steris Cmax XLT Surgical TableFQO · Traditional | STERIS Corporation | 03/20/2009SE |
| K972810 | OPT80 the Transportable (OPT80)FQO · Traditional | O.P.T. USA, Inc. | 08/26/1997SE |
| K971988 | Allen, Ultra and Smart SocketsFQO · Traditional | Allen Medical Systems, Inc. | 07/11/1997SE |
| K971307 | Amsco Surgical TableFQO · Traditional | STERIS Corporation | 06/27/1997SE |
| 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 |
|---|---|---|
| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
| K931872 | The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional | 02/07/1994SE |
| K922485 | Chemdi-Vhp Chemical IndicatorJOJ · Traditional | 09/29/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | 12/24/1986SE |
| K844479 | ChemsporFRC · Traditional | 11/25/1985SN |
Questions and answers
When was Quantum 3080 Surgical Table cleared by the FDA?
Quantum 3080 Surgical Table (K930493) received a 510(k) decision of Substantially Equivalent on June 22, 1993, 141 days after the submission was received.
What is the product code of K930493?
The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.