EchoGo Heart Failure (2.0)
K-Number: K240013 · 2024-09-23
ApplicantUltromics Limited
Decision Date2024-09-23
Product CodeQUO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EchoGo Heart Failure (2.0) is a medical device manufactured by Ultromics Limited. It received FDA 510(k) clearance on 2024-09-23 under approval number K240013. 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 (2.0)?
EchoGo Heart Failure (2.0) is a medical device that received FDA 510(k) clearance on 2024-09-23. It is manufactured by Ultromics Limited. The 510(k) number is K240013.
When was EchoGo Heart Failure (2.0) approved by the FDA?
EchoGo Heart Failure (2.0) received FDA 510(k) clearance on 2024-09-23, under approval number K240013.
What company makes EchoGo Heart Failure (2.0)?
EchoGo Heart Failure (2.0) is manufactured by Ultromics Limited.
What is the FDA product code for EchoGo Heart Failure (2.0)?
The FDA product code for EchoGo Heart Failure (2.0) is QUO.
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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.