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

    MODEL 330 SCREENING AUDIO METER, MODIFIED

    K Number: K926574 · Decision Mar 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    9
    Review Days
    89

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    Basic Information

    Device Name
    MODEL 330 SCREENING AUDIO METER, MODIFIED
    K Number
    K926574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Virtual Corp.
    Date Received
    December 30, 1992
    Decision Date
    March 29, 1993
    Product Code
    GWJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWJ Stimulator, Auditory, Evoked Response

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    Other Clearances by Virtual Corp.

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    K911689 MODEL 330 SCREENING AUDIOMETER
    K895443 MODEL 210 IMPEDANCE SYSTEM
    K896301 MODEL 340 PROBE MIC SYSTEM
    K863984 MODEL 320 TWO CHANNEL AUDIOMETER
    K853863 MODEL 310 IMPEDANCE SYSTEM