The following data is part of a premarket notification filed by Mimvista Corp. with the FDA for Mim 4.1 (seastar).
| Device ID | K071964 |
| 510k Number | K071964 |
| Device Name: | MIM 4.1 (SEASTAR) |
| 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 | 2007-07-16 |
| Decision Date | 2007-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865936000254 | K071964 | 000 |