EchoGo Heart Failure
K-Number: K222463 · 2022-11-23
ApplicantUltromics Limited
Decision Date2022-11-23
Product CodeQUO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EchoGo Heart Failure is a medical device manufactured by Ultromics Limited. It received FDA 510(k) clearance on 2022-11-23 under approval number K222463. The device is classified under product code QUO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EchoGo Heart Failure?
EchoGo Heart Failure is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by Ultromics Limited. The 510(k) number is K222463.
When was EchoGo Heart Failure approved by the FDA?
EchoGo Heart Failure received FDA 510(k) clearance on 2022-11-23, under approval number K222463.
What company makes EchoGo Heart Failure?
EchoGo Heart Failure is manufactured by Ultromics Limited.
What is the FDA product code for EchoGo Heart Failure?
The FDA product code for EchoGo Heart Failure is QUO.
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Related PubMed Literature
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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.