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510(k) Data Aggregation

    K Number
    K023147
    Device Name
    ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
    Manufacturer
    BORTEC BIOMEDICAL, LTD.
    Date Cleared
    2002-12-12

    (83 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    BORTEC BIOMEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bortec Biomedical Analog Multiplexed cable Telemetry (AMT) electromyograph is intended for non-invasive use as a research or diagnostic sensing and processing instrument in studies of physiological signals. The AMT is indicated for use with active or passive adult or pediatric subjects in hospitals or clinics under the direction of a health care professional during electromyography, including bio-feedback, evoked potential, kinesiological, nerve conductance and sleep studies.
    Device Description
    Analog Multiplexed cable Telemetry (AMT) electromyograph
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