The following data is part of a premarket notification filed by Barco N.v. with the FDA for Nio Color 2mp.
| Device ID | K133663 |
| 510k Number | K133663 |
| Device Name: | NIO COLOR 2MP |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO N.V. 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334031609 | K133663 | 000 |
| 05415334031593 | K133663 | 000 |
| 05415334037533 | K133663 | 000 |
| 05415334037526 | K133663 | 000 |