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510(k) Data Aggregation

    K Number
    K991770
    Device Name
    CUTANEOUS (GROUND) ELECTRODE
    Manufacturer
    NEURO SUPPLIES, INC.
    Date Cleared
    1999-08-18

    (86 days)

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

    CUTANEOUS (GROUND) ELECTRODE

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

    Cutaneous Ground Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding several electrodes. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The document is for a traditional medical device (electrodes) and predates widespread AI/ML applications in healthcare.

    Therefore, I cannot provide the requested information.

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