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    K Number
    K024373
    Device Name
    MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
    Manufacturer
    ELLTEC CO., LTD.
    Date Cleared
    2003-01-28

    (28 days)

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

    MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

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

    The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.

    Device Description

    The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.

    AI/ML Overview

    I am sorry but the provided document is a letter from the FDA regarding the substantial equivalence of an enteral nutrition warmer. It does not contain information about acceptance criteria, device performance, or related studies that typically describe the evaluation of AI/ML-based medical devices. Therefore, I cannot generate the requested table and information.

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