Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K061682 |
Device Name |
GE VOLUSON E8 ULTRASOUND SYSTEM |
Applicant |
GENERAL ELECTRIC CO. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
ALLEN SCHUH |
Correspondent |
GENERAL ELECTRIC CO. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
ALLEN SCHUH |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/15/2006 |
Decision Date | 07/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|