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FDA 510(k)

EchoS

K-Number: K180516 · 2018-10-19

ApplicantEcholight S.P.A
Decision Date2018-10-19
Product CodeMUA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoS is a medical device manufactured by Echolight S.P.A. It received FDA 510(k) clearance on 2018-10-19 under approval number K180516. 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?

EchoS is a medical device that received FDA 510(k) clearance on 2018-10-19. It is manufactured by Echolight S.P.A. The 510(k) number is K180516.

When was EchoS approved by the FDA?

EchoS received FDA 510(k) clearance on 2018-10-19, under approval number K180516.

What company makes EchoS?

EchoS is manufactured by Echolight S.P.A.

What is the FDA product code for EchoS?

The FDA product code for EchoS is MUA.

Other Devices by Echolight S.P.A

K202514EchoS Family 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. K202514EchoS FamilyEcholight 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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