510(k) K163712

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System by Shenzhen Wisonic Medical Technology Co. , Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2018
Date Received
December 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type