Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K000015 |
Device Name |
BARCOMED 2MP2 |
Applicant |
BARCO NV |
P.O. BOX 12038 |
LA JOLLA,
CA
92039 -2038
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
BARCO NV |
P.O. BOX 12038 |
LA JOLLA,
CA
92039 -2038
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/03/2000 |
Decision Date | 02/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|