The following data is part of a premarket notification filed by Oncology Data Systems, Inc. with the FDA for Mucheck - Monitor Unit Validation Program, Model V4.1.
| Device ID | K012227 |
| 510k Number | K012227 |
| Device Name: | MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ONCOLOGY DATA SYSTEMS, INC. 12401 S. RIVERVIEW RD. Oklahoma City, OK 73173 |
| Contact | Gregory G Miller |
| Correspondent | Gregory G Miller ONCOLOGY DATA SYSTEMS, INC. 12401 S. RIVERVIEW RD. Oklahoma City, OK 73173 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-10-01 |
| Summary: | summary |