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510(k) Data Aggregation

    K Number
    K991769
    Device Name
    CUTANEOUS (BAR) ELECTRODE
    Manufacturer
    NEURO SUPPLIES, INC.
    Date Cleared
    1999-08-18

    (86 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CUTANEOUS (BAR) ELECTRODE

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

    Cutaneous (Bar) Electrode is intended for non-invasive use as a recording (active/reference) or stimulating electrode during electromyographic (EMG), Nerve Conduction Studies(NCS), and Evoked Potentials (EP) recordings.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for several electrodes (cutaneous, digital ring, cutaneous disc, and cutaneous ground electrodes). It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter confirms that the devices are substantially equivalent to previously marketed devices and can therefore be marketed.

    Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory clearance, not a technical report detailing performance criteria or study results.

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