Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K163712 |
Device Name |
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System |
Applicant |
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. |
1ST AND 5TH FLOOR, NO.6 BUILDING, PINGSHAN TECH PARK |
TAOYUAN STREET, NANSHAN |
SHENZHEN,
CN
518055
|
|
Applicant Contact |
JIANG XIAOSAN |
Correspondent |
Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. |
8-9Th Floor, R&D Building, No.26 Qinglan Street |
Panyu District |
Guangzhou,
CN
510006
|
|
Correspondent Contact |
Mike Gu |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/30/2016 |
Decision Date | 01/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|