Device Classification Name |
Display, Diagnostic Radiology
|
510(k) Number |
K141428 |
Device Name |
MDMC-12133 |
Applicant |
BARCO N.V. |
35 PRESIDENT KENNEDYPARK |
KORTRIJK,
BE
8500
|
|
Applicant Contact |
LIEVEN DE WANDEL |
Correspondent |
BARCO N.V. |
35 PRESIDENT KENNEDYPARK |
KORTRIJK,
BE
8500
|
|
Correspondent Contact |
LIEVEN DE WANDEL |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/30/2014 |
Decision Date | 06/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|