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510(k) Data Aggregation

    K Number
    K973863
    Device Name
    MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR
    Manufacturer
    HI-TRONICS DESIGNS, INC.
    Date Cleared
    1998-01-02

    (85 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    HI-TRONICS DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient's ECG for the documentation of thythm and/or rate disturbances. The recorded ECG data can be transmitted over a telephone to a standard ECG receiver. The ECG transmissions are intended as aids in evaluating symptomatic episodes of rate disturbances, postmyocardial infarction follow-ups, anti-arrhythmia therapy, and cases that require ST segment analysis.
    Device Description
    The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient's ECG.
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