Carbon Fiber Conformal Couch Top
FDA 510(k) K973842 · Medtec, Inc.
510(k) numberK973842
Submission
- Device name
- Carbon Fiber Conformal Couch Top
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- October 8, 1997
- Decision date
- December 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K923775 | R-Made Head/Arm SupportIXQ · Traditional | R-Made, Inc. | 10/20/1992SE |
| K920729 | Bucky Table BK-12IXQ · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K914351 | Clinitron C-10IXQ · Traditional | Ssi Medical Services, Inc. | 02/14/1992SE |
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| K974703 | Carbon Fiber Breast BoardIYE · Traditional | 03/10/1998SE |
| K974700 | Matrix MT-MX3IYE · Traditional | 03/04/1998SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | 10/01/1996SE |
| K955236 | Green TEC-2100IWE · Traditional | 05/24/1996SE |
| K954705 | Acrysteel Blocking TrayIYE · Traditional | 01/05/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | 12/21/1995SE |
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Questions and answers
When was Carbon Fiber Conformal Couch Top cleared by the FDA?
Carbon Fiber Conformal Couch Top (K973842) received a 510(k) decision of Substantially Equivalent on December 5, 1997, 58 days after the submission was received.
What is the product code of K973842?
The FDA product code is IXQ – Table, Radiographic, Stationary Top, a Class II (moderate risk) device regulated under 21 CFR 892.1980.