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510(k) Data Aggregation

    K Number
    K990240
    Device Name
    ELECTROGLOTTOGRAPH
    Manufacturer
    KAY ELEMETRICS CORP.
    Date Cleared
    1999-03-11

    (45 days)

    Product Code
    KLX
    Regulation Number
    874.1325
    Why did this record match?
    Product Code :

    KLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device use would be indicated in those cases where vocal fold contact information is considered helpful in evaluating physiologically normal speakers for research purposes or clinically in cases of vocal fold pathologies.
    Device Description
    Electroglottograph
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