The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Diagnostic X-ray Patient Exposure Indicator.
| Device ID | K941931 |
| 510k Number | K941931 |
| Device Name: | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR |
| Classification | System, X-ray, Stationary |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Contact | Linda S Morin |
| Correspondent | Linda S Morin VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-20 |
| Decision Date | 1994-05-26 |