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

    THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER

    K Number: K913356 · Decision Dec 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
    K Number
    K913356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Monitor Instruments, Inc.
    Date Received
    July 30, 1991
    Decision Date
    December 5, 1991
    Product Code
    EWO
    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
    EWO Audiometer

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    Other Clearances by Monitor Instruments, Inc.

    K Number Device Name
    K922383 THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO