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

    SOLO MICROPUMP INSULIN DELIVERY SYSTEM

    K Number: K093364 · Decision Jan 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    89

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SOLO MICROPUMP INSULIN DELIVERY SYSTEM
    K Number
    K093364
    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
    October 28, 2009
    Decision Date
    January 25, 2010
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LZG), ordered by most recent decision date.

    Pivot Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Modular Medical MODD1 Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Extended Reservoir; MiniMed Reservoir

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Omnipod GO Insulin Delivery Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Extended Reservoir

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Medingo , Ltd.

    K Number Device Name
    K090245 SOLO INSULIN PATCH PUMP