Centralite Backpointer
FDA 510(k) K954414 · Diacor, Inc.
510(k) numberK954414
Submission
- Device name
- Centralite Backpointer
- Applicant
- Diacor, Inc.
Salt Lake City, UT, US - Received
- September 21, 1995
- Decision date
- October 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K950293 | TEC-2110 Green Laser Model Mt-HngIWE · Traditional | Medtec, Inc. | 08/18/1995SE |
| K950112 | Centralite(R)-Dll SeriesIWE · Traditional | Diacor, Inc. | 08/16/1995SE |
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| K943802 | HP Back Pointer SystemIWE · Traditional | Medtec, Inc. | 12/07/1994SE |
| K943381 | Laser Alignment ToolIWE · Traditional | Philips Medical Systems North America, Inc. | 08/09/1994SE |
| K941169 | Tec 2101 (Model Mt-Hplgd)IWE · Traditional | Medtec, Inc. | 07/18/1994SE |
| K935760 | Tec 2100 (Model Mt-Lplgd)IWE · Traditional | Medtec, Inc. | 01/25/1994SE |
More from Medtec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121929 | Zephyr 'X-Series Patient Transfer SledFRZ · Traditional | 01/17/2013SE |
| K050888 | Integra Immobilization SystemIYE · Traditional | 05/23/2005SE |
| K953046 | Peri-PusherIYE · Traditional | 09/22/1995SE |
| K950112 | Centralite(R)-Dll SeriesIWE · Traditional | 08/16/1995SE |
| K934566 | RadassistIYE · Traditional | 11/03/1993SE |
| K930246 | MammorxIYE · Traditional | 07/26/1993SE |
| K893398 | Centralite BackpointerIWE · Traditional | 08/17/1989SE |
| K872489 | CentraliteIWE · Traditional | 07/15/1987SE |
| K860193 | PortalcastIXI · Traditional | 01/30/1986SE |
Questions and answers
When was Centralite Backpointer cleared by the FDA?
Centralite Backpointer (K954414) received a 510(k) decision of Substantially Equivalent on October 23, 1995, 32 days after the submission was received.
What is the product code of K954414?
The FDA product code is IWE – Monitor, Patient Position, Light-Beam, a Class I (low risk) device regulated under 21 CFR 892.5780.