FDA 510(k)

iLux儀器，iLux一次性用品

K 號：K172645 · 2017-12-26

決定日期2017-12-26

產品代碼ORZ

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

iLux Instrument, iLux Disposable is the device name listed in this FDA 510(k) record. The listed applicant is Tear Film Innovations, Inc.. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K172645. The device is classified under product code ORZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iLux Instrument, iLux Disposable?

iLux Instrument, iLux Disposable is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Tear Film Innovations, Inc.. The 510(k) number is K172645.

When did iLux Instrument, iLux Disposable receive FDA 510(k) clearance?

iLux Instrument, iLux Disposable received FDA 510(k) clearance on 2017-12-26, under 510(k) number K172645.

Who is the listed applicant for iLux Instrument, iLux Disposable?

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

What is the FDA product code for iLux Instrument, iLux Disposable?

The FDA product code for iLux Instrument, iLux Disposable is ORZ.

其他以 Tear Film Innovations, Inc. 為申請人之記錄

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K200400Systane iLux2

相關器械（代碼：ORZ）

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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官方來源

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