FDA 510(k)

EchoS 家族

K 號：K202514 · 2021-02-25

決定日期2021-02-25

產品代碼MUA

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Echolight S.P.A 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K212851EchoSK 和 EchoSGyn 模組，適用於 EchoS 系列設備 K180516回聲S

相關器械（代碼：MUA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K211350Bindex BI-2Bone Index Finland , Ltd.K180516回聲SEcholight S.P.A K161919超掃描650Cyberlogic, Inc.K161971Bindex BI-2Bone Index Finland , Ltd.K152020Bindex BI-100Bone Index Finland , Ltd.

官方來源

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