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510(k) Data Aggregation

    K Number
    K993878
    Device Name
    JE 2000
    Manufacturer
    JACK'S ELECTRODES
    Date Cleared
    2000-02-01

    (78 days)

    Product Code
    IKN,GWP
    Regulation Number
    890.1375
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The electromyograph is intended to be used by a licensed practitioner, for the purpose of diagnostic neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the JE2000 Electromyograph. This document primarily focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.

    Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) is not available within the provided text.

    The document does state the Indications for Use: "The electromyograph is intended to be used by a licensed practitioner, for the purpose of diagnostic neurological procedures."

    To answer your questions, I would need a different type of document, such as a 510(k) Summary of Safety and Effectiveness, a clinical study report, or a comprehensive technical report for the JE2000 Electromyograph.

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