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    K Number
    K122040
    Device Name
    INVOTEC LARYNGEAL ELECTRODE
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    2013-10-31

    (476 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INVOTEC LARYNGEAL ELECTRODE

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

    The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the Invotec Laryngeal Electrode, stating its substantial equivalence to legally marketed predicate devices. It lists the indications for use but does not include any performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

    Therefore, I cannot provide the requested information based on the input text.

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