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FDA 510(k)

EchoSK and EchoSGyn modules for EchoS Family devices

K-Number: K212851 · 2022-03-16

ApplicantEcholight S.P.A
Decision Date2022-03-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoSK and EchoSGyn modules for EchoS Family devices is a medical device manufactured by Echolight S.P.A. It received FDA 510(k) clearance on 2022-03-16 under approval number K212851. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoSK and EchoSGyn modules for EchoS Family devices?

EchoSK and EchoSGyn modules for EchoS Family devices is a medical device that received FDA 510(k) clearance on 2022-03-16. It is manufactured by Echolight S.P.A. The 510(k) number is K212851.

When was EchoSK and EchoSGyn modules for EchoS Family devices approved by the FDA?

EchoSK and EchoSGyn modules for EchoS Family devices received FDA 510(k) clearance on 2022-03-16, under approval number K212851.

What company makes EchoSK and EchoSGyn modules for EchoS Family devices?

EchoSK and EchoSGyn modules for EchoS Family devices is manufactured by Echolight S.P.A.

What is the FDA product code for EchoSK and EchoSGyn modules for EchoS Family devices?

The FDA product code for EchoSK and EchoSGyn modules for EchoS Family devices is IYO.

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Other Devices by Echolight S.P.A

K180516EchoS K202514EchoS Family

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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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