FDA 510(k)

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K 號：K232346 · 2023-10-27

決定日期2023-10-27

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

Digital Expert Access with Remote Scanning is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232346. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital Expert Access with Remote Scanning?

Digital Expert Access with Remote Scanning is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is GE Healthcare. The 510(k) number is K232346.

When did Digital Expert Access with Remote Scanning receive FDA 510(k) clearance?

Digital Expert Access with Remote Scanning received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232346.

Who is the listed applicant for Digital Expert Access with Remote Scanning?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Expert Access with Remote Scanning?

The FDA product code for Digital Expert Access with Remote Scanning is LNH.

其他以 GE Healthcare 為申請人之記錄

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相關器械（代碼：LNH）

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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