The following data is part of a premarket notification filed by Barco N.v. with the FDA for Mdmc-12133.
| Device ID | K141428 |
| 510k Number | K141428 |
| Device Name: | MDMC-12133 |
| Classification | Display, Diagnostic Radiology |
| 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 | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2014-06-27 |
| Summary: | summary |