Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K101149 |
Device Name |
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
Applicant |
GE VINGMED ULTRASOUND AS |
9900 W INNOVATION DR. RP-2138 |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
BRYAN BEHN |
Correspondent |
GE VINGMED ULTRASOUND AS |
9900 W INNOVATION DR. RP-2138 |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
BRYAN BEHN |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/23/2010 |
Decision Date | 10/13/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|