Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K120741 |
Device Name |
VOLUSON S6, VOLUSON S8 |
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 | 03/12/2012 |
Decision Date | 04/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|