RS85 Diagnostic Ultrasound System
K-Number: K191115 · 2019-06-12
ApplicantSamsung Medison Co., Ltd.
Decision Date2019-06-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RS85 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2019-06-12 under approval number K191115. 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 RS85 Diagnostic Ultrasound System?
RS85 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K191115.
When was RS85 Diagnostic Ultrasound System approved by the FDA?
RS85 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-06-12, under approval number K191115.
What company makes RS85 Diagnostic Ultrasound System?
RS85 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for RS85 Diagnostic Ultrasound System?
The FDA product code for RS85 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.