FDA 510(k)

InBody

K 號：K200442 · 2020-12-04

決定日期2020-12-04

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

InBody is the device name listed in this FDA 510(k) record. The listed applicant is Inbody Co., Ltd.. It received FDA 510(k) clearance on 2020-12-04 under 510(k) number K200442. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InBody?

InBody is a medical device that received FDA 510(k) clearance on 2020-12-04. The listed applicant is Inbody Co., Ltd.. The 510(k) number is K200442.

When did InBody receive FDA 510(k) clearance?

InBody received FDA 510(k) clearance on 2020-12-04, under 510(k) number K200442.

Who is the listed applicant for InBody?

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

What is the FDA product code for InBody?

The FDA product code for InBody is DXN.

其他以 Inbody Co., Ltd. 為申請人之記錄

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相關器械（代碼：DXN）

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。

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官方來源

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