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FDA 510(k)

EchoS Family

K-Number: K202514 · 2021-02-25

ApplicantEcholight S.P.A
Decision Date2021-02-25
Product CodeMUA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoS Family is a medical device manufactured by Echolight S.P.A. It received FDA 510(k) clearance on 2021-02-25 under approval number K202514. The device is classified under product code MUA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoS Family?

EchoS Family is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Echolight S.P.A. The 510(k) number is K202514.

When was EchoS Family approved by the FDA?

EchoS Family received FDA 510(k) clearance on 2021-02-25, under approval number K202514.

What company makes EchoS Family?

EchoS Family is manufactured by Echolight S.P.A.

What is the FDA product code for EchoS Family?

The FDA product code for EchoS Family is MUA.

Other Devices by Echolight S.P.A

K180516EchoS K212851EchoSK and EchoSGyn modules for EchoS Family devices

Related Devices (Code: MUA)

K152020Bindex BI-100Bone Index Finland , Ltd. K161919UltraScan 650Cyberlogic, Inc. K161971Bindex BI-2Bone Index Finland , Ltd. K180516EchoSEcholight S.P.A K211350Bindex BI-2Bone Index Finland , Ltd.

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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