The following data is part of a premarket notification filed by Mevis Medical Solutions Ag with the FDA for Visia Neuro.
| Device ID | K113701 |
| 510k Number | K113701 |
| Device Name: | VISIA NEURO |
| Classification | System, Image Processing, Radiological |
| Applicant | MEVIS MEDICAL SOLUTIONS AG N27 W24075 PAUL COURT SUITE 100 Pewaukee, WI 53072 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes MEVIS MEDICAL SOLUTIONS AG N27 W24075 PAUL COURT SUITE 100 Pewaukee, WI 53072 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-12-16 |
| Decision Date | 2012-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260483290169 | K113701 | 000 |