The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Diamentor Patient X-ray Exposure Indicator 07302.
| Device ID | K853753 |
| 510k Number | K853753 |
| Device Name: | DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302 |
| Classification | System, X-ray, Stationary |
| Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Contact | Glasser |
| Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-10-02 |