BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GLOTTAL FREQUENCY ANALYSER

    K Number: K841832 · Decision Jul 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    GLOTTAL FREQUENCY ANALYSER
    K Number
    K841832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1325
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Teltec Electronic Equipment AB
    Date Received
    May 3, 1984
    Decision Date
    July 18, 1984
    Product Code
    KLX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KLX Electroglottograph

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