BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SOLO INSULIN PATCH PUMP

    K Number: K090245 · Decision Jul 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    171

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    Basic Information

    Device Name
    SOLO INSULIN PATCH PUMP
    K Number
    K090245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medingo , Ltd.
    Date Received
    February 2, 2009
    Decision Date
    July 23, 2009
    Product Code
    LZG
    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
    LZG Pump, Infusion, Insulin

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    Other Clearances by Medingo , Ltd.

    K Number Device Name
    K093364 SOLO MICROPUMP INSULIN DELIVERY SYSTEM