The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 3mp (mdnc-3421).
| Device ID | K170837 |
| 510k Number | K170837 |
| Device Name: | Nio Color 3MP (MDNC-3421) |
| 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 | 2017-03-21 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001916 | K170837 | 000 |
| 05415334001688 | K170837 | 000 |
| 05415334028326 | K170837 | 000 |