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    K Number
    K040525
    Device Name
    SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
    Manufacturer
    SONTRA MEDICAL INC.
    Date Cleared
    2004-08-17

    (169 days)

    Product Code
    NRJ
    Regulation Number
    878.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONTRA MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and The Oollar Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.
    Device Description
    The SonoPrep® Ultrasonic Skin Permeation System is a portable battery operated reusable device that disrupts the stratum corneum layer of the skin by means of cavitation of a fluid with ultrasonic energy. The result of the treatment allows the rapid onset of topical OTC lidocaine 4%.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONTRA MEDICAL INC.

    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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