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510(k) Data Aggregation

    K Number
    K103115
    Device Name
    PRODIGY DIABETES MANAGEMENT SOFTWARE
    Manufacturer
    PRODIGY DIABETES CARE, LLC.
    Date Cleared
    2011-10-12

    (356 days)

    Product Code
    NBW, DEV, JQP
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRODIGY DIABETES CARE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data. The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.
    Device Description
    The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL Server 2005 Server 2005.
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