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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 the device name listed in this FDA 510(k) record. The listed applicant is Icardio.Ai. It received FDA 510(k) clearance on 2024-10-10 under 510(k) 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. The listed applicant is Icardio.Ai. The 510(k) number is K241430.

When did EchoMeasure receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoMeasure?

The FDA 510(k) record lists Icardio.Ai as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoMeasure?

The FDA product code for EchoMeasure is QIH.

Other records listing Icardio.Ai as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.