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

    MODEL 330 SCREENING AUDIOMETER

    K Number: K911689 · Decision Oct 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    9
    Review Days
    188

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    Basic Information

    Device Name
    MODEL 330 SCREENING AUDIOMETER
    K Number
    K911689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Virtual Corp.
    Date Received
    April 16, 1991
    Decision Date
    October 21, 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 Virtual Corp.

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    K926574 MODEL 330 SCREENING AUDIO METER, MODIFIED
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    K896301 MODEL 340 PROBE MIC SYSTEM
    K863984 MODEL 320 TWO CHANNEL AUDIOMETER
    K853863 MODEL 310 IMPEDANCE SYSTEM