Green TEC-2100
FDA 510(k) K955236 · Medtec, Inc.
510(k) numberK955236
Submission
- Device name
- Green TEC-2100
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- November 14, 1995
- Decision date
- May 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
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| K111340 | Head and Neck Immobilization System, Body Immobilization SystemLNH · Traditional | 06/28/2011SE |
| K093738 | MRI Patient Positioning DevicesLNH · Traditional | 05/14/2010SE |
| K974703 | Carbon Fiber Breast BoardIYE · Traditional | 03/10/1998SE |
| K974700 | Matrix MT-MX3IYE · Traditional | 03/04/1998SE |
| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | 12/05/1997SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | 10/01/1996SE |
| K954705 | Acrysteel Blocking TrayIYE · Traditional | 01/05/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | 12/21/1995SE |
| K954225 | Med-Tec Hand GripIXQ · Traditional | 11/14/1995SE |
Questions and answers
When was Green TEC-2100 cleared by the FDA?
Green TEC-2100 (K955236) received a 510(k) decision of Substantially Equivalent on May 24, 1996, 192 days after the submission was received.
What is the product code of K955236?
The FDA product code is IWE – Monitor, Patient Position, Light-Beam, a Class I (low risk) device regulated under 21 CFR 892.5780.