FDA 510(k)

LipiView II 眼表干涉儀

K 號：K152869 · 2016-01-14

決定日期2016-01-14

產品代碼HKI

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

LipiView II Ocular Surface Interferometer is the device name listed in this FDA 510(k) record. The listed applicant is Tearscience, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152869. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LipiView II Ocular Surface Interferometer?

LipiView II Ocular Surface Interferometer is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Tearscience, Inc.. The 510(k) number is K152869.

When did LipiView II Ocular Surface Interferometer receive FDA 510(k) clearance?

LipiView II Ocular Surface Interferometer received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152869.

Who is the listed applicant for LipiView II Ocular Surface Interferometer?

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

What is the FDA product code for LipiView II Ocular Surface Interferometer?

The FDA product code for LipiView II Ocular Surface Interferometer is HKI.

其他以 Tearscience, 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。

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相關器械（代碼：HKI）

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。

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom Technologies K252120眼底攝影手機非散瞳型 (FOP NM-10)Remidio Innovative Solutions Private Limited K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd K250683眼底攝影機Optain Health, Inc.

官方來源

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