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510(k) Data Aggregation

    K Number
    K102856
    Device Name
    SIROCCO THERMAL REGULATING SYSTEM
    Date Cleared
    2011-06-30

    (274 days)

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

    GALMAZ BIOTECH S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Galmaz Biotech® SIROCCO™ Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.
    Device Description
    The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).
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