The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 3mp And Mdnc-3121.
| Device ID | K090732 |
| 510k Number | K090732 |
| Device Name: | NIO COLOR 3MP AND MDNC-3121 |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-19 |
| Decision Date | 2009-04-20 |