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510(k) Data Aggregation

    K Number
    K020564
    Device Name
    EAV KINDLING 2000S GSR DEVICE
    Manufacturer
    VIRBRANT HEALTH
    Date Cleared
    2002-04-30

    (69 days)

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

    VIRBRANT HEALTH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
    Device Description
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