Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K101236 |
Device Name |
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM |
Applicant |
GE HEALTHCARE |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
BRYAN BEHN |
Correspondent |
GE HEALTHCARE |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
BRYAN BEHN |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/03/2010 |
Decision Date | 02/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|