EchoGo Core
K-Number: K191171 · 2019-11-13
ApplicantUltromics, Ltd.
Decision Date2019-11-13
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EchoGo Core is a medical device manufactured by Ultromics, Ltd.. It received FDA 510(k) clearance on 2019-11-13 under approval number K191171. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EchoGo Core?
EchoGo Core is a medical device that received FDA 510(k) clearance on 2019-11-13. It is manufactured by Ultromics, Ltd.. The 510(k) number is K191171.
When was EchoGo Core approved by the FDA?
EchoGo Core received FDA 510(k) clearance on 2019-11-13, under approval number K191171.
What company makes EchoGo Core?
EchoGo Core is manufactured by Ultromics, Ltd..
What is the FDA product code for EchoGo Core?
The FDA product code for EchoGo Core is QIH.
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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.