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    K Number
    K032935
    Device Name
    EPI-SCAN, MODEL P 100
    Manufacturer
    EDX EPI-SCAN, INC.
    Date Cleared
    2003-11-20

    (59 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    EDX EPI-SCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the measurement of galvanic skin response.
    Device Description
    The development of the Epi-Scan P100 has been based on the combined principles of instrumentation and the electrophysiological effects of innervation of the sweat glands. This provides a noninvasive, painless instrument system fore the quantitative measurement of Selective Tissue Conductance, which has been operationally defined as "…the relative ability of biological tissue to conduct a weak (DC) electrical signal, which is applied for a selected period of time to a selected, limited and restricted surface area of that tissue ... " and which shares those same neuroanatomic reflex pathways as other tests of sympathetic skin activity or regional perspiration levels.
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