Device Classification Name |
system, x-ray, angiographic
|
510(k) Number |
K941946 |
Device Name |
LCA ANGIOGRAPHIC IMAGING SYSTEM |
Applicant |
GE MEDICAL SYSTEMS |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
LARRY KROGER |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 04/21/1994 |
Decision Date | 05/20/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|