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

    EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

    K Number: K080587 · Decision May 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    10
    Review Days
    73

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    Basic Information

    Device Name
    EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
    K Number
    K080587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Animas Corp.
    Date Received
    March 3, 2008
    Decision Date
    May 15, 2008
    Product Code
    MRZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRZ Accessories, Pump, Infusion

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    Other Clearances by Animas Corp.

    K Number Device Name
    K080639 SYMPHONY GLUCOSE MANAGEMENT SYSTEM
    K063674 EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
    K042873 ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
    K032257 MODEL IR 1200 INSULIN PUMP
    K022394 EZMANAGER PLUS
    K021700 ANIMUS EZSERTER INFUSION SET INSERTER
    K021439 MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
    K012754 EZ SET INFUSION SET
    K993184 R1000 SERIES INSULIN PUMP