BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARCTIC BLAST INTRAVENOUS FLUID CHILLER

    K Number: K080899 · Decision Aug 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    12
    Review Days
    129

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    Basic Information

    Device Name
    ARCTIC BLAST INTRAVENOUS FLUID CHILLER
    K Number
    K080899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medivance, Inc.
    Date Received
    March 31, 2008
    Decision Date
    August 7, 2008
    Product Code
    NCX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCX System, Hypothermia, Intravenous, Cooling

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    Other Clearances by Medivance, Inc.

    K Number Device Name
    K251974 Arctic Sun Temperature Management System (Model 5000)
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    K200225 Arctic Sun Stat Temperature Management System
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    K120849 HYBRID ARCTICGEL PAD
    K110956 MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
    K101092 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
    K071341 MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
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