FDA 510(k)

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

K 號：K181627 · 2018-08-10

決定日期2018-08-10

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

Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb 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 2018-08-10 under 510(k) number K181627. 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 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner?

Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K181627.

When did Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner receive FDA 510(k) clearance?

Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner received FDA 510(k) clearance on 2018-08-10, under 510(k) number K181627.

Who is the listed applicant for Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb 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 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner?

The FDA product code for Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb 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 K200416波士頓一步液體酵素清潔劑Bausch & Lomb, Incorporated 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.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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