FDA 510(k)

內視鏡型號 EN-580T，過管 TS-1314B，氣球 BS-4，管套組 TY-500D

K 號：K223295 · 2023-01-11

決定日期2023-01-11

產品代碼FDA

諮詢委員會GU

決定相當於

器材摘要

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K223295. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D?

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Fujifilm Corporaton. The 510(k) number is K223295.

When did Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D receive FDA 510(k) clearance?

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D received FDA 510(k) clearance on 2023-01-11, under 510(k) number K223295.

Who is the listed applicant for Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D?

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 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D?

The FDA product code for Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D is FDA.

其他以 Fujifilm Corporaton 為申請人之記錄

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相關器械（代碼：FDA）

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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