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FDA 510(k)

富士通內視鏡型號 EI-740D/S

K 號:K221551 · 2023-01-27

決定日期2023-01-27
產品代碼FDS
諮詢委員會GU
決定相當於

器材摘要

FUJIFILM Endoscope Model EI-740D/S is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K221551. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUJIFILM Endoscope Model EI-740D/S?

FUJIFILM Endoscope Model EI-740D/S is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Fujifilm Corporaton. The 510(k) number is K221551.

When did FUJIFILM Endoscope Model EI-740D/S receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EI-740D/S received FDA 510(k) clearance on 2023-01-27, under 510(k) number K221551.

Who is the listed applicant for FUJIFILM Endoscope Model EI-740D/S?

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 Endoscope Model EI-740D/S?

The FDA product code for FUJIFILM Endoscope Model EI-740D/S is FDS.

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:FDS)

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。

官方來源

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