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

    ELECTROGLOTTOGRAPH

    K Number: K990240 · Decision Mar 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    ELECTROGLOTTOGRAPH
    K Number
    K990240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1325
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kay Elemetrics Corp.
    Date Received
    January 25, 1999
    Decision Date
    March 11, 1999
    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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