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FDA 510(k)

EchoMeasure

K-Number: K241430 · 2024-10-10

ApplicantIcardio.Ai
Decision Date2024-10-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoMeasure is a medical device manufactured by Icardio.Ai. It received FDA 510(k) clearance on 2024-10-10 under approval number K241430. 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 EchoMeasure?

EchoMeasure is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by Icardio.Ai. The 510(k) number is K241430.

When was EchoMeasure approved by the FDA?

EchoMeasure received FDA 510(k) clearance on 2024-10-10, under approval number K241430.

What company makes EchoMeasure?

EchoMeasure is manufactured by Icardio.Ai.

What is the FDA product code for EchoMeasure?

The FDA product code for EchoMeasure is QIH.

Other Devices by Icardio.Ai

K251293CardioVision

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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.

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