FDA 510(k)

iCare HOME2

K 號：K211355 · 2022-01-25

決定日期2022-01-25

產品代碼HKY

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

iCare HOME2 is the device name listed in this FDA 510(k) record. The listed applicant is Icare Finland OY. It received FDA 510(k) clearance on 2022-01-25 under 510(k) number K211355. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iCare HOME2?

iCare HOME2 is a medical device that received FDA 510(k) clearance on 2022-01-25. The listed applicant is Icare Finland OY. The 510(k) number is K211355.

When did iCare HOME2 receive FDA 510(k) clearance?

iCare HOME2 received FDA 510(k) clearance on 2022-01-25, under 510(k) number K211355.

Who is the listed applicant for iCare HOME2?

The FDA 510(k) record lists Icare Finland OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCare HOME2?

The FDA product code for iCare HOME2 is HKY.

其他以 Icare Finland OY 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。

K241447iCare ST500 (TA04)K220852iCare IC200 K200966愛康家用水銀式眼壓計 K190316愛康 ic200 K163343愛康居家式眼壓計 K153694愛康 ic100

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相關器械（代碼：HKY）

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。

K241447iCare ST500 (TA04)Icare Finland OY K233516Tono-Vera® 靈敏度計與Ocu-Dot® 靈敏度計探針（16305、16306、16318）Reichert, Inc.K234037CATS-L 電子眼壓計™ 球面鏡Cats Tonometer, LLC K232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OY K203850CATS®-D 靈敏度計棱鏡Cats Tonometer, LLC

官方來源

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