The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Radioisotope Calibrator Model 34-062.
| Device ID | K850815 |
| 510k Number | K850815 |
| Device Name: | RADIOISOTOPE CALIBRATOR MODEL 34-062 |
| Classification | Calibrator, Dose, Radionuclide |
| 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 | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-28 |
| Decision Date | 1985-08-21 |