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510(k) Data Aggregation

    K Number
    K122483
    Device Name
    PEARL DIABETES MANAGEMENT SYSTEM
    Date Cleared
    2013-01-03

    (142 days)

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

    Asante Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pearl™ Diabetes Management System is intended for 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 and an infusion set adapter. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery. It attaches to the pump body. The pump body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The infusion set adapter is the conduit from the insulin cartridge to the final delivery tubing.
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