WS80A Diagnostic Ultrasound System
K-Number: K153529 · 2016-02-02
ApplicantSamsung Medison Co., Ltd.
Decision Date2016-02-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
WS80A Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2016-02-02 under approval number K153529. 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 WS80A Diagnostic Ultrasound System?
WS80A Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-02-02. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K153529.
When was WS80A Diagnostic Ultrasound System approved by the FDA?
WS80A Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-02-02, under approval number K153529.
What company makes WS80A Diagnostic Ultrasound System?
WS80A Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for WS80A Diagnostic Ultrasound System?
The FDA product code for WS80A 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.