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510(k) Data Aggregation

    K Number
    K100567
    Device Name
    PEARL DIABETES MANAGEMENT SYSTEM
    Manufacturer
    M2 GROUP HOLDINGS, INC.
    Date Cleared
    2011-05-10

    (435 days)

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

    M2 GROUP HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
    Device Description
    The Pearl Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body, a single use adapter and associated accessories. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery and attaches to the pump body. The pump body provides the drive mechanism and battery power for pre-filled insulin cartridges. The adapter connects the insulin cartridge to the infusion set and contains the occlusion sensor.
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