Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K121063 |
Device Name |
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
GE MEDICAL SYSTEM ISRAEL LTD. |
9900 INNOVATION DR |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
BRYAN BEHN |
Correspondent |
GE MEDICAL SYSTEM ISRAEL LTD. |
9900 INNOVATION DR |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
BRYAN BEHN |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/06/2012 |
Decision Date | 08/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|