SENS-A-RAY
Unit, X-ray, Extraoral With Timer
REGAM MEDICAL SYSTEMS
The following data is part of a premarket notification filed by Regam Medical Systems with the FDA for Sens-a-ray.
Pre-market Notification Details
| Device ID | K923067 |
| 510k Number | K923067 |
| Device Name: | SENS-A-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | REGAM MEDICAL SYSTEMS 631 MONYTOYAL BLVD. NORTH VANCOUVER, B.C. V7r 2g2 Canada, CA |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1992-11-27 |
Trademark Results [SENS-A-RAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENS-A-RAY 74136926 1709867 Dead/Cancelled |
AFP IMAGING CORPORATION 1991-02-06 |
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