FDA 510(k)

EchoS

K-Number: K180516 · 2018-10-19

Decision Date2018-10-19

Product CodeMUA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EchoS is the device name listed in this FDA 510(k) record. The listed applicant is Echolight S.P.A. It received FDA 510(k) clearance on 2018-10-19 under 510(k) 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. The listed applicant is Echolight S.P.A. The 510(k) number is K180516.

When did EchoS receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoS?

The FDA 510(k) record lists Echolight S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoS?

The FDA product code for EchoS is MUA.

Other records listing Echolight S.P.A 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.

K212851EchoSK and EchoSGyn modules for EchoS Family devices K202514EchoS Family

Related Devices (Code: MUA)

K211350Bindex BI-2Bone Index Finland , Ltd.K202514EchoS FamilyEcholight S.P.A K161919UltraScan 650Cyberlogic, Inc.K161971Bindex BI-2Bone Index Finland , Ltd.K152020Bindex BI-100Bone Index Finland , Ltd.

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.