BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BIONIME DIABETES MANAGEMENT SYSTEM VI.0

    K Number: K113007 · Decision Feb 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    77
    Applicant Total
    21
    Review Days
    143

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    Basic Information

    Device Name
    BIONIME DIABETES MANAGEMENT SYSTEM VI.0
    K Number
    K113007
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionime Corporation
    Date Received
    October 7, 2011
    Decision Date
    February 27, 2012
    Product Code
    JQP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JQP Calculator/Data Processing Module, For Clinical Use

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