The following data is part of a premarket notification filed by Medical Dosimetry Services, Inc. with the FDA for Mucheck Monitor Unit Validation Program.
| Device ID | K980904 |
| 510k Number | K980904 |
| Device Name: | MUCHECK MONITOR UNIT VALIDATION PROGRAM |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL DOSIMETRY SERVICES, INC. 12401 SOUTH RIVERVIEW RD. Oklahoma City, OK 73173 -8403 |
| Contact | Gregory Miller |
| Correspondent | Gregory Miller MEDICAL DOSIMETRY SERVICES, INC. 12401 SOUTH RIVERVIEW RD. Oklahoma City, OK 73173 -8403 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-10 |
| Decision Date | 1998-06-08 |
| Summary: | summary |