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

    HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

    K Number: K051040 · Decision May 24, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    29
    Review Days
    29

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    Basic Information

    Device Name
    HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
    K Number
    K051040
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5680
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Perfusion Systems
    Date Received
    April 25, 2005
    Decision Date
    May 24, 2005
    Product Code
    JOX
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOX Analyzer, Heparin, Automated

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