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FDA 510(k)

EchoGo Core (2.0)

K-Number: K213275 · 2021-12-20

ApplicantUltromics Limited
Decision Date2021-12-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoGo Core (2.0) is a medical device manufactured by Ultromics Limited. It received FDA 510(k) clearance on 2021-12-20 under approval number K213275. 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 EchoGo Core (2.0)?

EchoGo Core (2.0) is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Ultromics Limited. The 510(k) number is K213275.

When was EchoGo Core (2.0) approved by the FDA?

EchoGo Core (2.0) received FDA 510(k) clearance on 2021-12-20, under approval number K213275.

What company makes EchoGo Core (2.0)?

EchoGo Core (2.0) is manufactured by Ultromics Limited.

What is the FDA product code for EchoGo Core (2.0)?

The FDA product code for EchoGo Core (2.0) is QIH.

Other Devices by Ultromics Limited

K222463EchoGo Heart Failure K240860EchoGo Amyloidosis (1.0) K240013EchoGo Heart Failure (2.0)

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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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