The following data is part of a premarket notification filed by Barco N.v. with the FDA for Nivr58-t Kit.
| Device ID | K161880 |
| 510k Number | K161880 |
| Device Name: | NIVR58-T Kit |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | Barco N.V. President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel Barco N.V. President Kennedypark 35 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 | 2016-07-08 |
| Decision Date | 2017-03-14 |
| Summary: | summary |