The following data is part of a premarket notification filed by Barco N.v. with the FDA for Sivr56-t Kit.
| Device ID | K133994 |
| 510k Number | K133994 |
| Device Name: | SIVR56-T KIT |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | BARCO N.V. 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO N.V. 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-12-01 |