BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Z0174, IMPEDANCE AUDIOMETER

    K Number: K845049 · Decision May 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    17
    Review Days
    176

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    Basic Information

    Device Name
    Z0174, IMPEDANCE AUDIOMETER
    K Number
    K845049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Madsen Electronics (Canada) , Ltd.
    Date Received
    November 26, 1984
    Decision Date
    May 21, 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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