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510(k) Data Aggregation

    K Number
    K961263
    Device Name
    MODEL 1200 ABMULATORY INFUSION PUMP
    Manufacturer
    PATIENT SOLUTIONS, INC.
    Date Cleared
    1996-08-23

    (143 days)

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

    The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.

    Device Description

    The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The text describes a 510(k) summary for the "Model 1200 Ambulatory Infusion Pump" and focuses on establishing its substantial equivalency to existing legally marketed devices. It details the device's description, intended use, and technological characteristics, but it does not include performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be needed to answer your request.

    Therefore, I cannot provide a response with the requested information based on the input given.

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