HERA W9, HERA W10 Diagnostic Ultrasound System
K-Number: K211824 · 2021-09-09
ApplicantSamsung Medison Co., Ltd.
Decision Date2021-09-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HERA W9, HERA W10 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2021-09-09 under approval number K211824. 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 HERA W9, HERA W10 Diagnostic Ultrasound System?
HERA W9, HERA W10 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-09. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K211824.
When was HERA W9, HERA W10 Diagnostic Ultrasound System approved by the FDA?
HERA W9, HERA W10 Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-09, under approval number K211824.
What company makes HERA W9, HERA W10 Diagnostic Ultrasound System?
HERA W9, HERA W10 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for HERA W9, HERA W10 Diagnostic Ultrasound System?
The FDA product code for HERA W9, HERA W10 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.