The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 5.8mp (mdnc-6121).
| Device ID | K170476 |
| 510k Number | K170476 |
| Device Name: | Nio Color 5.8MP (MDNC-6121) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Helena Soenen |
| Correspondent | Helena Soenen 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 | 2017-02-16 |
| Decision Date | 2017-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001992 | K170476 | 000 |
| 05415334044029 | K170476 | 000 |
| 05415334044036 | K170476 | 000 |
| 05415334044043 | K170476 | 000 |
| 05415334028401 | K170476 | 000 |
| 05415334036888 | K170476 | 000 |
| 05415334036895 | K170476 | 000 |
| 05415334001138 | K170476 | 000 |
| 05415334000131 | K170476 | 000 |
| 05415334001695 | K170476 | 000 |
| 05415334043787 | K170476 | 000 |