The following data is part of a premarket notification filed by Medical High Technology International, Inc. with the FDA for Mhti Ct-sim Radiation Therapy Treatment Simulator.
| Device ID | K873580 |
| 510k Number | K873580 |
| Device Name: | MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | MEDICAL HIGH TECHNOLOGY INTERNATIONAL, INC. 14155 58TH ST., NORTH Clearwater, FL 34620 |
| Contact | Thomas P Monkus |
| Correspondent | Thomas P Monkus MEDICAL HIGH TECHNOLOGY INTERNATIONAL, INC. 14155 58TH ST., NORTH Clearwater, FL 34620 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-27 |
| Decision Date | 1987-11-02 |