The following data is part of a premarket notification filed by Barco N.v. with the FDA for Coronis Uniti.
Device ID | K151505 |
510k Number | K151505 |
Device Name: | Coronis Uniti |
Classification | Display, Diagnostic Radiology |
Applicant | Barco N.V. President Kennedypark 35 Kortrijk, BE 8500 |
Contact | Franky Dubois |
Correspondent | Franky Dubois Barco N.V. President Kennedypark 35 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 | 2015-06-04 |
Decision Date | 2015-07-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CORONIS UNITI 79161827 4938882 Live/Registered |
BARCO N.V. 2015-01-19 |