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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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, #6 Bldg., Pingshan Tech Park
Taoyuan St., Nanshan
Shenzhen,  CN 518055
Applicant Contact JIANG XIAOSAN
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/30/2016
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
Predetermined Change
Control Plan Authorized		 No
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