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

    HEPARIN DOSE RESPONSE CARTRIDGE

    K Number: K102953 · Decision Nov 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    209
    Review Days
    31

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    Basic Information

    Device Name
    HEPARIN DOSE RESPONSE CARTRIDGE
    K Number
    K102953
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5680
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    October 4, 2010
    Decision Date
    November 4, 2010
    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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