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510(k) Data Aggregation

    K Number
    K063008
    Device Name
    HEALTH CHECK KIOSK
    Manufacturer
    XPEREX CORPORATION
    Date Cleared
    2007-06-07

    (248 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    XPEREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Health Check Kiosk is indicated for use by the general public so that a user can measure his/her own health parameters using devices cleared for use by the public. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
    Device Description
    The Health Check Kiosk is a kiosk that is erected in public spaces, and provides a location where the general public can measure various health parameters. The Health Check kiosks are intended only to provide information, and are not for diagnostic use. No charge is made for use of the kiosk, but advertising may be posted inside of it. It is planned to locate the kiosk in non-medical settings such as gyms, corporate offices and retail stores.
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