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510(k) Data Aggregation

    K Number
    K103077
    Device Name
    ECG PEN
    Date Cleared
    2011-07-13

    (268 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN DYNAMICS BIOMEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vion.ECG Pen (Model no.: 800E) is intended for recording ECG data and displaying general information by adult patients who are concerned their heart rhythm and waveform. This Vion.ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits. In addition, the patient can also record their ECG data and transmit the recorded data to personal computer. The Vion.ECG Pen is not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemakers are not recommended to use this device. This device is not intended to substitute a conventional diagnostic tool.
    Device Description
    The MD's Vion.800E ECG Pen is a small, portable and easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of your heart rhythm. Each ECG reading records 30 seconds measurement and these ECG readings can help your doctor monitor your condition. The unit included build-in memory that can store up to 99 measurements, including the ECG data along with date and time of measurement. With USB interface, it allows you or your doctor to view detail information of measurement. Furthermore, Vion® ECG Pen (Model no.: 800E) has similar general design with the Omron HCG-801 portable ECG Monitor (K060766 ) marketed by Omron Healthcare, Inc.. & MD100 Handheld ECG Monitor (K080933) marketed by Beijing Choice Electronic Technology Co., Ltd.
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