Dura-Board Armboard
FDA 510(k) K964273 · Allen Medical Systems, Inc.
510(k) numberK964273
Submission
- Device name
- Dura-Board Armboard
- Applicant
- Allen Medical Systems, Inc.
Cleveland, OH, US - Received
- October 28, 1996
- Decision date
- January 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDC – Table, Operating-Room, Electrical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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| 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 |
| 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 |
|---|---|---|
| K971988 | Allen, Ultra and Smart SocketsFQO · Traditional | 07/11/1997SE |
| K960027 | High Volume I.V. & Irrigation TowerFOX · Traditional | 03/12/1996SE |
| K944779 | Carbon Lights Hand Surgery TableFWZ · Traditional | 10/14/1994SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | 04/21/1993SE |
Questions and answers
When was Dura-Board Armboard cleared by the FDA?
Dura-Board Armboard (K964273) received a 510(k) decision of Substantially Equivalent on January 8, 1997, 72 days after the submission was received.
What is the product code of K964273?
The FDA product code is GDC – Table, Operating-Room, Electrical, a Class I (low risk) device regulated under 21 CFR 878.4960.