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

    INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

    K Number: K080908 · Decision Oct 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    199

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    Basic Information

    Device Name
    INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
    K Number
    K080908
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innercool Therapies, Inc.- A Delaware Corporation
    Date Received
    April 1, 2008
    Decision Date
    October 17, 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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