FDA 510(k)

卡迪歐琳 touchECG

K 號：K160746 · 2016-11-02

決定日期2016-11-02

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

CARDIOLINE touchECG is the device name listed in this FDA 510(k) record. The listed applicant is Cardioline S.P.A. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K160746. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARDIOLINE touchECG?

CARDIOLINE touchECG is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Cardioline S.P.A. The 510(k) number is K160746.

When did CARDIOLINE touchECG receive FDA 510(k) clearance?

CARDIOLINE touchECG received FDA 510(k) clearance on 2016-11-02, under 510(k) number K160746.

Who is the listed applicant for CARDIOLINE touchECG?

The FDA 510(k) record lists Cardioline S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOLINE touchECG?

The FDA product code for CARDIOLINE touchECG is DPS.

其他以 Cardioline S.P.A 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。

K220526HD+12, HD+15 K160840ECG100+、ECG200+

相關器械（代碼：DPS）

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。

K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs 霍爾特平台Philips France Commercial

官方來源

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