Clivia series Diagnostic Ultrasound System
K-Number: K211886 · 2021-12-02
Decision Date2021-12-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Clivia series Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2021-12-02 under approval number K211886. 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 Clivia series Diagnostic Ultrasound System?
Clivia series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-12-02. It is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K211886.
When was Clivia series Diagnostic Ultrasound System approved by the FDA?
Clivia series Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-12-02, under approval number K211886.
What company makes Clivia series Diagnostic Ultrasound System?
Clivia series Diagnostic Ultrasound System is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd..
What is the FDA product code for Clivia series Diagnostic Ultrasound System?
The FDA product code for Clivia series Diagnostic Ultrasound System is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.