The following data is part of a premarket notification filed by Medicalibration Physics Consultant Services, Inc. with the FDA for Compute-rx-comp (tm).
| Device ID | K910367 |
| 510k Number | K910367 |
| Device Name: | COMPUTE-RX-COMP (TM) |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC. 1463 HARVEST DR. Ripon, CA 95366 |
| Contact | Ralph H Rydman |
| Correspondent | Ralph H Rydman MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC. 1463 HARVEST DR. Ripon, CA 95366 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-05-30 |