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510(k) Data Aggregation

    K Number
    K071085
    Device Name
    E3-80 PORTABLE ECG RECORDER & ANALYZER
    Date Cleared
    2007-10-03

    (169 days)

    Product Code
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-STAR INTERNATIONAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The E3-80 device is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment. The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.
    Device Description
    The E3-80 ECG device is designed to be a portable recorder of electrocardiograms. The device has a storage function in which the recorded signals are automatically stored in a removable storage disc for trained healthcare practitioners to perform further analysis using PC-based software. The E3-80 ECG device is a light-weight, pocket-size portable recorder of three channel electrocardiograms. The device has adequate battery life and recording capability for continuous recording of the ambulatory ECG signals for up to 24 hours. The recorded signals are automatically stored in a removable Secure Digital (SD) disc for trained healthcare practitioners to perform further analysis using PC-based software.
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