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510(k) Data Aggregation

    K Number
    K020907
    Device Name
    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
    Manufacturer
    MEDICOTEST A/S
    Date Cleared
    2002-06-14

    (86 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

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

    The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Neuroline Subdermal Needle Electrode. This type of letter declares substantial equivalence to a predicate device and permits marketing. It is not a study report or a summary of acceptance criteria and performance data.

    Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, ground truth establishment, training set size) is not available within this document.

    The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailing the technical specifications and clinical study results that would typically contain the information you've requested.

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