FDA 510(k)

美尼康3%過氧化氫清潔消毒液

K 號：K191872 · 2020-03-02

決定日期2020-03-02

產品代碼LPN

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

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K191872. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K191872.

When did Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution receive FDA 510(k) clearance?

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution received FDA 510(k) clearance on 2020-03-02, under 510(k) number K191872.

Who is the listed applicant for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

FDA 510(k) 記錄將 Menicon Co, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

The FDA product code for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is LPN.

其他以 Menicon Co, Ltd. 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。

K262495美如1日上昇（米法立酮A）K253795美尼塞普3%過氧化氫清潔與消毒液 K193399美如1日上昇（米法立酮A）K180819一日式平裝（hioxifilcon A）每日抛弃式軟性隐形眼鏡 K180004美尼康ASRB（asmofilcon A）矽膠水凝軟性隐形眼镜 K173136美尼康Progent蛋白移除劑用於硬式透气性隐形眼鏡

查看所有 7 項裝置 →

相關器械（代碼：LPN）

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。

K253795美尼塞普3%過氧化氫清潔與消毒液Menicon Co, Ltd.K222541Bausch + Lomb無防腐劑潤滑和重新潤濕眼藥水Bausch & Lomb, Incorporated K221263Aqua Naina Plus 無菌鹽水溶液Chemtex USA, Inc.K202932ABT12 多功能溶液Bausch & Lomb, Incorporated K210051OTE MPS 045 多功能鏡片保養液Ote North America, LLC K193441Aqua Naina 無菌鹽水溶液Chemtex USA, Inc.

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。