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510(k) Data Aggregation

    K Number
    K040957
    Device Name
    NOA III ENTERAL NUTRITION PUMP
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2004-05-21

    (38 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOA III ENTERAL NUTRITION PUMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates. The pump is designed to be used in hospital and home care environments. The pump can be used in stationary and ambulatory ways.

    Device Description

    The NOA III Enteral Nutrition System includes: Infusion Pump, Battery Charger.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Caesarea Medical Electronics Limited regarding their NOA III Enteral Nutrition Pump. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their submission, but the letter itself does not detail the specific performance studies or acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text. The document is primarily an approval letter, not a device performance report.

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