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510(k) Data Aggregation

    K Number
    K111737
    Device Name
    DISPOSABLE ELECTRODE
    Manufacturer
    SANIBEL SUPPLY
    Date Cleared
    2011-10-14

    (115 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable adhesive electrode for standard neurophysiological examinations

    Device Description

    Disposable Electrode

    AI/ML Overview

    The provided text {0-2} describes an FDA 510(k) premarket notification for the "Sanibel Disposable Electrodes." It includes information about the device's classification, regulation number, and indications for use.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.

    This document is a regulatory approval letter and an "Indications for Use" statement, not a scientific study report. Therefore, I cannot generate the requested table and study description based on the provided text.

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