LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K980410
    Device Name
    SLE ELECTRODES AND ACCESSORIES
    Manufacturer
    SPECIALIZED LABORATORY EQUIPMENT, LTD.
    Date Cleared
    1998-10-22

    (261 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALIZED LABORATORY EQUIPMENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.
    Device Description
    The SLE Electrodes and Accessories device is a cutaneous electrode.
    Ask a Question
    K Number
    K981004
    Device Name
    SLE EMG ELECTRODES AND ACCESSORIES
    Manufacturer
    SPECIALIZED LABORATORY EQUIPMENT, LTD.
    Date Cleared
    1998-10-21

    (217 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALIZED LABORATORY EQUIPMENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.
    Device Description
    The SLE EMG Electrodes and Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.
    Ask a Question

    Page 1 of 1