Voluson E10
K-Number: K201768 · 2020-10-22
ApplicantGE Healthcare
Decision Date2020-10-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Voluson E10 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2020-10-22 under approval number K201768. 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 Voluson E10?
Voluson E10 is a medical device that received FDA 510(k) clearance on 2020-10-22. It is manufactured by GE Healthcare. The 510(k) number is K201768.
When was Voluson E10 approved by the FDA?
Voluson E10 received FDA 510(k) clearance on 2020-10-22, under approval number K201768.
What company makes Voluson E10?
Voluson E10 is manufactured by GE Healthcare.
What is the FDA product code for Voluson E10?
The FDA product code for Voluson E10 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.