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510(k) Data Aggregation

    K Number
    K973529
    Device Name
    NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
    Manufacturer
    MEDICOTEST A/S
    Date Cleared
    1997-11-20

    (63 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, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES

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

    Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

    Device Description

    Neuroline, Disposable Concentric Needle Electrode

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Neuroline, Disposable Concentric Needle Electrode." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device performance study. It is a regulatory clearance document for a physical medical device.

    Therefore, I cannot fulfill your request for the specific information points as they are not present in the provided input.

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