BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TEMPEDY

    K Number: K152946 · Decision Sep 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    345

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    Basic Information

    Device Name
    TEMPEDY
    K Number
    K152946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seiratherm GmbH
    Date Received
    October 6, 2015
    Decision Date
    September 15, 2016
    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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