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FDA 510(k)

EchoGo Pro

K-Number: K201555 · 2020-12-18

ApplicantUltromics, Ltd.
Decision Date2020-12-18
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoGo Pro is a medical device manufactured by Ultromics, Ltd.. It received FDA 510(k) clearance on 2020-12-18 under approval number K201555. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoGo Pro?

EchoGo Pro is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Ultromics, Ltd.. The 510(k) number is K201555.

When was EchoGo Pro approved by the FDA?

EchoGo Pro received FDA 510(k) clearance on 2020-12-18, under approval number K201555.

What company makes EchoGo Pro?

EchoGo Pro is manufactured by Ultromics, Ltd..

What is the FDA product code for EchoGo Pro?

The FDA product code for EchoGo Pro is POK.

Other Devices by Ultromics, Ltd.

K191171EchoGo Core

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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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