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

    MODEL 322 CLINICAL AUDIOMETER

    K Number: K930203 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    9
    Review Days
    175

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    Basic Information

    Device Name
    MODEL 322 CLINICAL AUDIOMETER
    K Number
    K930203
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Virtual Corp.
    Date Received
    January 14, 1993
    Decision Date
    July 8, 1993
    Product Code
    EWD
    Advisory Committee
    Unknown
    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
    EWD Protector, Hearing (Insert)

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    Other Clearances by Virtual Corp.

    K Number Device Name
    K960500 THE VIRTUAL M-332
    K934715 MODEL 222 CLINICAL AUDIOMETER
    K926574 MODEL 330 SCREENING AUDIO METER, MODIFIED
    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