FDA 510(k)

LSN 醫療設備規範文本翻譯如下： LSN 注意事項：在翻譯中，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和URL均保持原樣。

K 號：K201092 · 2020-10-29

決定日期2020-10-29

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

LSN is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Biometrics, LLC. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K201092. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LSN?

LSN is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Imaging Biometrics, LLC. The 510(k) number is K201092.

When did LSN receive FDA 510(k) clearance?

LSN received FDA 510(k) clearance on 2020-10-29, under 510(k) number K201092.

Who is the listed applicant for LSN?

The FDA 510(k) record lists Imaging Biometrics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LSN?

The FDA product code for LSN is JAK.

其他以 Imaging Biometrics, LLC 為申請人之記錄

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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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