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510(k) Data Aggregation

    K Number
    K052295
    Device Name
    CARDIOSOFT PC ECG, USB VERSION
    Manufacturer
    Date Cleared
    2006-01-13

    (143 days)

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

    CARDIOSOFT, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioSoft PC ECG is intended for use in acquiring, processing, recording, archiving and displaying electrocardiographic information. It can provide serial comparison of ECG information to facilitate review of current and previous records and is intended for use by trained operators. The system offers no diagnostic opinion to the user, but may be used by a physician to render his or her own medical opinion.
    Device Description
    The CardioSoft PC ECG is an electrocardiograph that detects signals associated with cardiac activity and produces an ECG graphical record. The device operates on a personal computer through a USB hardware module. The device can acquire, process, record, archive and display 3-, 6-, or 12-lead ECG and vector cardiograms. The device provides portable ECG with important advantages compared to traditional machines.
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