FDA 510(k)

FFRangio 医療設備規範文本翻譯： FFRangio 医療設備規範文本

K 號：K192442 · 2019-12-09

決定日期2019-12-09

產品代碼QEK

諮詢委員會履歷

決定相當於

器材摘要

FFRangio is the device name listed in this FDA 510(k) record. The listed applicant is Cathworks, Ltd.. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K192442. The device is classified under product code QEK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FFRangio?

FFRangio is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Cathworks, Ltd.. The 510(k) number is K192442.

When did FFRangio receive FDA 510(k) clearance?

FFRangio received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192442.

Who is the listed applicant for FFRangio?

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

What is the FDA product code for FFRangio?

The FDA product code for FFRangio is QEK.

其他以 Cathworks, 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。

K182149FFRangio 系統

相關器械（代碼：QEK）

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。

K182149FFRangio 系統Cathworks, Ltd.

官方來源

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