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510(k) Data Aggregation

    K Number
    K041318
    Device Name
    MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
    Manufacturer
    MEDTRONIC MINIMED
    Date Cleared
    2004-07-19

    (62 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medtronic MiniMed Paradigm Model 511 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets without AI assistance. The document is a 510(k) clearance letter for the Medtronic MiniMed Paradigm Model 511 Insulin Pump, which confirms its substantial equivalence to a predicate device. It does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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