RS80A Diagnostic Ultrasound System
K-Number: K153539 · 2016-10-03
ApplicantSamsung Medison Co., Ltd.
Decision Date2016-10-03
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RS80A Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2016-10-03 under approval number K153539. 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 RS80A Diagnostic Ultrasound System?
RS80A Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K153539.
When was RS80A Diagnostic Ultrasound System approved by the FDA?
RS80A Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-10-03, under approval number K153539.
What company makes RS80A Diagnostic Ultrasound System?
RS80A Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for RS80A Diagnostic Ultrasound System?
The FDA product code for RS80A 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.