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510(k) Data Aggregation

    K Number
    K012825
    Device Name
    HEARTTRENDS
    Manufacturer
    LEV-EL, LTD.
    Date Cleared
    2002-03-19

    (208 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEV-EL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.
    Device Description
    The HeartTrends™ software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment. It provides measurements of the MPW (Multipole Paramater Weighted) HRV. The HeartTrends™ software is based on an algorithm, which is constructed The HeartTronos - sorvice, based on a physical-mathematical description of complex time series. The multipole method generates several parameters, multipoles, where every single one describes the HRV.
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