HM70A Diagnostic Ultrasound System
K-Number: K182894 · 2019-01-22
ApplicantSamsung Medison Co., Ltd.
Decision Date2019-01-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HM70A Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2019-01-22 under approval number K182894. 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 HM70A Diagnostic Ultrasound System?
HM70A Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K182894.
When was HM70A Diagnostic Ultrasound System approved by the FDA?
HM70A Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-01-22, under approval number K182894.
What company makes HM70A Diagnostic Ultrasound System?
HM70A Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for HM70A Diagnostic Ultrasound System?
The FDA product code for HM70A 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.