Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K152567 |
Device Name |
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System |
Applicant |
GE Healthcare |
3114 N. Grandview Blvd. |
Waukesha,
WI
53188
|
|
Applicant Contact |
Ayesha Pergadia |
Correspondent |
GE Healthcare |
3114 N. Grandview Blvd. |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Ayesha Pergadia |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/09/2015 |
Decision Date | 11/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|