The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Model 37-720 Dual Diode Dosimetry System.
Device ID | K940660 |
510k Number | K940660 |
Device Name: | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
Contact | Linda S Morin |
Correspondent | Linda S Morin VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-15 |
Decision Date | 1994-12-09 |