FDA 510(k)

EchoSK 和 EchoSGyn 模块，适用于 EchoS 家族设备

K号: K212851 · 2022-03-16

决定日期2022-03-16

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

EchoSK and EchoSGyn modules for EchoS Family devices 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 2022-03-16 under 510(k) number K212851. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Echolight S.P.A. The 510(k) number is K212851.

When did EchoSK and EchoSGyn modules for EchoS Family devices receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoSK and EchoSGyn modules for EchoS Family devices?

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 EchoSK and EchoSGyn modules for EchoS Family devices?

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

列明Echolight S.P.A为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K202514EchoS 家族 K180516EchoS

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