Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K003931 |
Device Name |
VIVID 7 WITH SONOPAC, MODEL FB0008XX |
Applicant |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
ALLEN SCHUH |
Correspondent |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
ALLEN SCHUH |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2000 |
Decision Date | 01/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|