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FDA 510(k)

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

K-Number: K163712 · 2018-01-02

Decision Date2018-01-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-01-02 under approval number K163712. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System?

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-01-02. It is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K163712.

When was Clover 50/Clover60/Clover70 Diagnostic Ultrasound System approved by the FDA?

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-01-02, under approval number K163712.

What company makes Clover 50/Clover60/Clover70 Diagnostic Ultrasound System?

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd..

What is the FDA product code for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System?

The FDA product code for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is IYN.

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Official Source

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