富士通視覺內視鏡 EL-R740M30 医療設備規範文本
K 號：K212950 · 2021-12-02
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器材摘要
FUJIFILM Video Laparoscope EL-R740M30 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K212950. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FUJIFILM Video Laparoscope EL-R740M30?
FUJIFILM Video Laparoscope EL-R740M30 is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Fujifilm Corporaton. The 510(k) number is K212950.
When did FUJIFILM Video Laparoscope EL-R740M30 receive FDA 510(k) clearance?
FUJIFILM Video Laparoscope EL-R740M30 received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212950.
Who is the listed applicant for FUJIFILM Video Laparoscope EL-R740M30?
The FDA 510(k) record lists Fujifilm Corporaton as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FUJIFILM Video Laparoscope EL-R740M30?
The FDA product code for FUJIFILM Video Laparoscope EL-R740M30 is GCJ.
相關臨床試驗
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其他以 Fujifilm Corporaton 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。
相關器械（代碼：GCJ）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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