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    K Number
    K100071
    Device Name
    EMCOOLSPAD
    Manufacturer
    EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG
    Date Cleared
    2010-10-12

    (274 days)

    Product Code
    NZE
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients.
    Device Description
    The EMCOOLSpad is a single use surface (skin) cooling device, which is adherent to the patien's skin and so highly adjustable during the cooling procedure. An EMCOOLSpad consists of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material, stored frozen at 0 to -10°C.
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