FDA 510(k)

Aqua Naina Plus 無菌鹽水溶液

K 號：K221263 · 2022-10-12

決定日期2022-10-12

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

Aqua Naina Plus Sterile Saline Solution is the device name listed in this FDA 510(k) record. The listed applicant is Chemtex USA, Inc.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K221263. 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 Aqua Naina Plus Sterile Saline Solution?

Aqua Naina Plus Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Chemtex USA, Inc.. The 510(k) number is K221263.

When did Aqua Naina Plus Sterile Saline Solution receive FDA 510(k) clearance?

Aqua Naina Plus Sterile Saline Solution received FDA 510(k) clearance on 2022-10-12, under 510(k) number K221263.

Who is the listed applicant for Aqua Naina Plus Sterile Saline Solution?

The FDA 510(k) record lists Chemtex USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aqua Naina Plus Sterile Saline Solution?

The FDA product code for Aqua Naina Plus Sterile Saline Solution is LPN.

其他以 Chemtex USA, Inc. 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。

K193441Aqua Naina 無菌鹽水溶液

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 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.K200747PuriLens Plus 非防腐鹽水性溶液The Lifestyle Company, Inc.

官方來源

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