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FDA 510(k)

enspire 3000 清潔及液體化學消毒處理系統

K 號：K243433 · 2024-12-02

申請人STERIS Corporation
決定日期2024-12-02
產品代碼FEB
諮詢委員會GU
決定相當於

器材摘要

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2024-12-02 under 510(k) number K243433. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is STERIS Corporation. The 510(k) number is K243433.

When did enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System receive FDA 510(k) clearance?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2024-12-02, under 510(k) number K243433.

Who is the listed applicant for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

The FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is FEB.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 STERIS 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。

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相關器械（代碼：FEB）

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。

K241168系統83旋轉內視鏡清潔/消毒器Wassenburg Medical, Inc.K230930enspire 3000 清潔及液體化學無菌處理系統STERIS CorporationK213833範圍 BUDDY PLUS 絞道清潔輔助設備Medivators, Inc.K201920內視鏡再處理器 OER-EliteOlympus Medical Systems Corp.K173590系統83 Plus 洗淨/消毒機Custom Ultrasonics, Inc.K190969內鏡再處理器 OER-EliteOlympus Medical Systems Corp.

官方來源

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