The following data is part of a premarket notification filed by Barco N.v. with the FDA for Nexxis Or, Nexxis.
| Device ID | K170537 |
| 510k Number | K170537 |
| Device Name: | Nexxis OR, Nexxis |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | Barco N.v. Beneluxpark 21 Kortrijk, BE 8500 |
| Contact | Eric Caus |
| Correspondent | Eric Caus Barco N.v. Beneluxpark 21 Kortrijk, BE 8500 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-23 |
| Decision Date | 2017-04-21 |
| Summary: | summary |