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510(k) Data Aggregation

    K Number
    K994300
    Device Name
    NASOGASTRIC TUBE HOLDER, MODEL 160
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-02-10

    (51 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The new Dale NasoGastric Tube Holder securely holds nasoenteric and nasogastric tubes in the nares.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device: Dale® NasoGastric Tube Holder, Model 160. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document is a regulatory approval, not a technical report detailing performance studies. Therefore, I cannot extract the requested information from the provided text.

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