The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 2mp (mdnc-2123).
| Device ID | K171812 |
| 510k Number | K171812 |
| Device Name: | Nio Color 2MP (MDNC-2123) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Helena Soenen |
| Correspondent | Lieven Dewandel Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334002029 | K171812 | 000 |
| 05415334000384 | K171812 | 000 |
| 05415334000377 | K171812 | 000 |
| 05415334002623 | K171812 | 000 |
| 05415334002616 | K171812 | 000 |
| 05415334002609 | K171812 | 000 |
| 05415334002357 | K171812 | 000 |