The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for 37-701-1 Patient Doase Monitor With Detectors.
| Device ID | K860469 |
| 510k Number | K860469 |
| Device Name: | 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS |
| Classification | Generator, High Voltage, X-ray, Therapeutic |
| 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 | KPZ |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-06 |
| Decision Date | 1986-04-16 |