LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K953356
    Device Name
    EMG RECORDING RING ELECTRODE
    Manufacturer
    CHALGREN ENTERPRISES, INC.
    Date Cleared
    1996-01-22

    (189 days)

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

    EMG RECORDING RING ELECTRODE

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

    Not Found

    Device Description

    EMG Recording Ring Electrode

    AI/ML Overview

    The provided text is a letter from the FDA to Chalgren Enterprises, Inc. regarding a 510(k) notification for an EMG Recording Ring Electrode. It states that the device is substantially equivalent to legally marketed devices.

    This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I am unable to provide the requested details based on the input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1