BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ASRA, SCREENING AUDIOMETER

    K Number: K914232 · Decision Jan 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    ASRA, SCREENING AUDIOMETER
    K Number
    K914232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mercury Electronics (Scot) , Ltd.
    Date Received
    September 20, 1991
    Decision Date
    January 31, 1992
    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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