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510(k) Data Aggregation

    K Number
    K991771
    Device Name
    DIGITAL RING ELECTRDE
    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
    Predicate For
    K101139
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Digital Ring Electrode is intended for non-invasive use as a recording electrode during electromyographic (EMG) recordings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and an "Intended Use Statement" for a Digital Ring Electrode. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    However, it does not include details about:

    • Acceptance criteria and reported device performance in a table format.
    • Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    The document discusses regulatory clearance, but not the technical study details you've asked for.

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