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

    MODEL 310 IMPEDANCE SYSTEM

    K Number: K853863 · Decision Dec 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    9
    Review Days
    92

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    Basic Information

    Device Name
    MODEL 310 IMPEDANCE SYSTEM
    K Number
    K853863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Virtual Corp.
    Date Received
    September 17, 1985
    Decision Date
    December 18, 1985
    Product Code
    ETY
    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
    ETY Tester, Auditory Impedance

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    Other Clearances by Virtual Corp.

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    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