富士通處理器EP-8000；富士通內視鏡型號EG-860R
K 號：K243260 · 2025-04-11
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器材摘要
FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K243260. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?
FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Fujifilm Corporation. The 510(k) number is K243260.
When did FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R receive FDA 510(k) clearance?
FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243260.
Who is the listed applicant for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?
FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R?
The FDA product code for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R is FET.
相關臨床試驗
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。
其他以 Fujifilm Corporation 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：FET）
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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