FDA 510(k)

EchoGo Heart Failure

K-Number: K222463 · 2022-11-23

Decision Date2022-11-23

Product CodeQUO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EchoGo Heart Failure is the device name listed in this FDA 510(k) record. The listed applicant is Ultromics Limited. It received FDA 510(k) clearance on 2022-11-23 under 510(k) 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. The listed applicant is Ultromics Limited. The 510(k) number is K222463.

When did EchoGo Heart Failure receive FDA 510(k) clearance?

EchoGo Heart Failure received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222463.

Who is the listed applicant for EchoGo Heart Failure?

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

What is the FDA product code for EchoGo Heart Failure?

The FDA product code for EchoGo Heart Failure is QUO.

Other records listing Ultromics Limited 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.

K240860EchoGo Amyloidosis (1.0)K240013EchoGo Heart Failure (2.0)K213275EchoGo Core (2.0)K201555EchoGo Pro K191171EchoGo Core

Related Devices (Code: QUO)

K251293CardioVisionIcardio.Ai K240013EchoGo Heart Failure (2.0)Ultromics Limited K223905Vivio® LVEDP SystemAvicena, LLC

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.