FDA 510(k)

波士頓一步液體酵素清潔劑

K 號：K200416 · 2020-09-23

決定日期2020-09-23

產品代碼MRC

諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文：本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。

決定相當於

器材摘要

Boston One Step Liquid Enzymatic Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K200416. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Boston One Step Liquid Enzymatic Cleaner?

Boston One Step Liquid Enzymatic Cleaner is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K200416.

When did Boston One Step Liquid Enzymatic Cleaner receive FDA 510(k) clearance?

Boston One Step Liquid Enzymatic Cleaner received FDA 510(k) clearance on 2020-09-23, under 510(k) number K200416.

Who is the listed applicant for Boston One Step Liquid Enzymatic Cleaner?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boston One Step Liquid Enzymatic Cleaner?

The FDA product code for Boston One Step Liquid Enzymatic Cleaner is MRC.

其他以 Bausch & Lomb, Incorporated 為申請人之記錄

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相關器械（代碼：MRC）

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。

K251876cleadew GP 水神一Ophtecs Corporation K201069VibrantVue 视網膜鹽水性Dry Eye Innovations, LLC K182984MaxiTears 接触鏡藥品設備規範文本Omnivision AG K181566NutrifillContamac, Ltd.K181627保仕亮波士頓多效解決方案，保仕亮波士頓一步液體酵素清潔劑Bausch & Lomb, Incorporated K180319保仕康波士頓先進清潔劑，保仕康波士頓先進調理液Bausch and Lomb, Incorporated

官方來源

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