FDA 510(k)

心電圖迷你系統連續心電圖監護儀及心律不整檢測器

K 號：K151269 · 2016-01-15

決定日期2016-01-15

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Technologies , Ltd.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151269. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Lifewatch Technologies , Ltd.. The 510(k) number is K151269.

When did ECG Mini System Continuous ECG Monitor and Arrhythmia Detector receive FDA 510(k) clearance?

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151269.

Who is the listed applicant for ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

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

What is the FDA product code for ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

The FDA product code for ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is DSI.

其他以 Lifewatch Technologies , Ltd. 為申請人之記錄

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K151835生命徵象貼片系統

相關器械（代碼：DSI）

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。

K243349BodyGuardian 遥測監控系統 (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® 電子無線行動心電圖監測與檢測系統（32000）Infobionic, Inc.K240177Zio AT® 裝置（A100A1001）iRhythm Technologies, Inc.K230265MoMe® ARC 電子無線行動心電圖監測與檢測系統Infobionic, Inc.K231276SmartCardia 7L 平臺Smartcardia SA K193104統一心律失常診斷系統口袋心電圖IVMedicalgorithmics S.A.

官方來源

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