The following data is part of a premarket notification filed by Mimvista Corp. with the FDA for Mim 4.0 (neuro.
| Device ID | K060816 |
| 510k Number | K060816 |
| Device Name: | MIM 4.0 (NEURO |
| Classification | System, Image Processing, Radiological |
| Applicant | MIMVISTA CORP. 25200 CHAGRIN BLVD. SUITE 200 Cleveland, OH 44122 |
| Contact | Peter Simmelink |
| Correspondent | Peter Simmelink MIMVISTA CORP. 25200 CHAGRIN BLVD. SUITE 200 Cleveland, OH 44122 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-05-16 |
| Summary: | summary |