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510(k) Data Aggregation

    K Number
    K093364
    Device Name
    SOLO MICROPUMP INSULIN DELIVERY SYSTEM
    Manufacturer
    Date Cleared
    2010-01-25

    (89 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDINGO LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Solo™ Insulin Patch Pump is for prescription use only.
    Device Description
    The Solo™ MicroPump Insulin Delivery System (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The MicroPump is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The MicroPump is controlled via a remote control unit. The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.
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    K Number
    K090245
    Device Name
    SOLO INSULIN PATCH PUMP
    Manufacturer
    Date Cleared
    2009-07-23

    (171 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDINGO LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Solo™ Insulin Patch Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Solo™ Insulin Patch Pump is for prescription use only.
    Device Description
    The Solo™ Insulin Patch Pump (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The patch is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The patch is controlled via a remote control unit. The Solo™ Insulin Patch Pump is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.
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