The following data is part of a premarket notification filed by Magus Microcontrollers, Inc. with the FDA for Mevassist(setup Controller).
| Device ID | K852609 |
| 510k Number | K852609 |
| Device Name: | MEVASSIST(SETUP CONTROLLER) |
| Classification | Accelerator, Linear, Medical |
| Applicant | MAGUS MICROCONTROLLERS, INC. 4252 COMMERCE CIRCLE VICTORIA, B.C. Canada V8z4mz, CA |
| Contact | Leo Ford |
| Correspondent | Leo Ford MAGUS MICROCONTROLLERS, INC. 4252 COMMERCE CIRCLE VICTORIA, B.C. Canada V8z4mz, CA |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-19 |
| Decision Date | 1986-02-06 |