The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Model 580-006 Radiation Therapy Ionization Chamber.
| Device ID | K982937 |
| 510k Number | K982937 |
| Device Name: | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Contact | Edward W Siurek, Iii |
| Correspondent | Edward W Siurek, Iii 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 | 1998-08-21 |
| Decision Date | 1998-11-19 |
| Summary: | summary |