Device Classification Name |
display, cathode-ray tube, medical
|
510(k) Number |
K122167 |
Device Name |
NEXXIS OR |
Applicant |
BARCO NV |
35 PRESIDENT KENNEDYPARK |
KORTRIJK,
BE
8500
|
|
Applicant Contact |
LIEVEN DE WANDEL |
Correspondent |
BARCO NV |
35 PRESIDENT KENNEDYPARK |
KORTRIJK,
BE
8500
|
|
Correspondent Contact |
LIEVEN DE WANDEL |
Regulation Number | 870.2450
|
Classification Product Code |
|
Date Received | 07/23/2012 |
Decision Date | 04/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|