FDA 510(k)

Bindex BI-2

K 號：K211350 · 2022-04-29

決定日期2022-04-29

產品代碼MUA

諮詢委員會RA

決定相當於

器材摘要

Bindex BI-2 is the device name listed in this FDA 510(k) record. The listed applicant is Bone Index Finland , Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K211350. 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 Bindex BI-2?

Bindex BI-2 is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Bone Index Finland , Ltd.. The 510(k) number is K211350.

When did Bindex BI-2 receive FDA 510(k) clearance?

Bindex BI-2 received FDA 510(k) clearance on 2022-04-29, under 510(k) number K211350.

Who is the listed applicant for Bindex BI-2?

The FDA 510(k) record lists Bone Index Finland , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bindex BI-2?

The FDA product code for Bindex BI-2 is MUA.

其他以 Bone Index Finland , Ltd. 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。

K161971Bindex BI-2 K152020Bindex BI-100

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。

K202514EchoS 家族Echolight S.P.A 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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