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510(k) Data Aggregation

    K Number
    K980378
    Device Name
    MELODIE INFUSION PUMP
    Manufacturer
    COMPAGNIE DE DEVELOPPEMENT AGUETTANT
    Date Cleared
    1998-12-09

    (313 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

    for use in the infusion of chemotherapy, antibiotherapy, patient controlled analgesia, anti-emetic therapy, parenteral nutrition, and other infusion therapies that require continuous, bolus or intermittent delivery.

    Device Description

    MELODIE INFUSION PUMP

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Melodie® Infusion Pump. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria. It is a regulatory approval letter, not a performance study report.

    Therefore, I cannot provide the requested information based on the input.

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