The following data is part of a premarket notification filed by Combinostics Oy with the FDA for Cneuro Cmri.
| Device ID | K171328 |
| 510k Number | K171328 |
| Device Name: | CNeuro CMRI |
| Classification | System, Image Processing, Radiological |
| Applicant | Combinostics Oy Hatanpaan Valtatie Tampere, FI 33100 |
| Contact | Lennart Thurfjell |
| Correspondent | Lennart Thurfjell Combinostics Oy Hatanpaan Valtatie Tampere, FI 33100 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-05 |
| Decision Date | 2018-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430070841021 | K171328 | 000 |