FDA 510(k)

EchoS 家族

K号: K202514 · 2021-02-25

决定日期2021-02-25

产品代码MUA

咨询委员会RA

决定实质等同

器械摘要

EchoS Family 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 2021-02-25 under 510(k) number K202514. The device is classified under product code MUA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EchoS Family?

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

When did EchoS Family receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoS Family?

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 Family?

The FDA product code for EchoS Family is MUA.

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。

K212851EchoSK 和 EchoSGyn 模块，适用于 EchoS 家族设备 K180516EchoS

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。