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510(k) Data Aggregation

    K Number
    K040942
    Device Name
    VST3
    Manufacturer
    BIOWATCH MEDICAL, INC.
    Date Cleared
    2004-09-15

    (156 days)

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

    BIOWATCH MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biowatch Medical VST3 is indicated for use to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, such as: - Arrhythmia or dysrhythmia . - Skipped beats or pauses ● - Rapid, slow, or irregular heart rate . - Lightheadedness or faintness ● - Palpitations . The VST records and transmits ECG data to a remote central receiving station for interpretation by certified critical care specialists and/or a licensed over-read physician to identify cardiac rhythm disorders. The device is not intended to sound any alarms
    Device Description
    The VST3 is an ambulatory ECG monitor. It is a wearable device capable of monitoring two channels of electrocardiogram. The device monitors each of the input channels and stores the information for later transmission via its cellular modem to a trained critical care specialist located at a remote clinical monitoring center. It provides real-time, continuous, interventional monitoring over extended periods of time. Additionally, upon receipt of appropriate commands, the device is capable of opening a cellular voice channel and/or transmitting its location information.
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