Tec 2101 (Model Mt-Hplgd)
FDA 510(k) K941169 · Medtec, Inc.
510(k) numberK941169
Submission
- Device name
- Tec 2101 (Model Mt-Hplgd)
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- March 14, 1994
- Decision date
- July 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K955236 | Green TEC-2100IWE · Traditional | Medtec, Inc. | 05/24/1996SE |
| K954414 | Centralite BackpointerIWE · Traditional | Diacor, Inc. | 10/23/1995SE |
| 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 |
| K951601 | Med-Tec String Reticle TrayIWE · Traditional | Medtec, Inc. | 05/11/1995SE |
| 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 |
| K935760 | Tec 2100 (Model Mt-Lplgd)IWE · Traditional | Medtec, Inc. | 01/25/1994SE |
More from Medtec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132908 | Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base…IYE · Traditional | 03/04/2014SE |
| 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 |
| K955236 | Green TEC-2100IWE · Traditional | 05/24/1996SE |
| K954705 | Acrysteel Blocking TrayIYE · Traditional | 01/05/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | 12/21/1995SE |
Questions and answers
When was Tec 2101 (Model Mt-Hplgd) cleared by the FDA?
Tec 2101 (Model Mt-Hplgd) (K941169) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 126 days after the submission was received.
What is the product code of K941169?
The FDA product code is IWE – Monitor, Patient Position, Light-Beam, a Class I (low risk) device regulated under 21 CFR 892.5780.