FDA 510(k)

EchoGo Core (2.0)

K-Number: K213275 · 2021-12-20

Decision Date2021-12-20

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EchoGo Core (2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ultromics Limited. It received FDA 510(k) clearance on 2021-12-20 under 510(k) 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. The listed applicant is Ultromics Limited. The 510(k) number is K213275.

When did EchoGo Core (2.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoGo Core (2.0)?

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 Core (2.0)?

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

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)K222463EchoGo Heart Failure K201555EchoGo Pro K191171EchoGo Core

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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.