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    K Number
    K023713
    Device Name
    SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
    Manufacturer
    SONTRA MEDICAL INC.
    Date Cleared
    2004-01-28

    (450 days)

    Product Code
    KRC
    Regulation Number
    870.2370
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    Product Code :

    KRC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG monitoring.
    Device Description
    The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System consists of a microprocessor controlled ultrasonic skin prep generator, a reusable handpiece, a reusable handheld contact electrode, coupling media and ECG electrodes used for ultrasonically treating intact skin in order to lower the skin impedance for the application of ECG electrodes for monitoring heart rates.
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