The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Model 37-185.
| Device ID | K973960 |
| 510k Number | K973960 |
| Device Name: | MODEL 37-185 |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Contact | Linda S Nash |
| Correspondent | Linda S Nash VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-16 |
| Decision Date | 1998-01-14 |
| Summary: | summary |