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

    OCTOTOXIC SCREENER

    K Number: K811790 · Decision Jul 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    OCTOTOXIC SCREENER
    K Number
    K811790
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1120
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Western Advanced Technology, Inc.
    Date Received
    June 24, 1981
    Decision Date
    July 15, 1981
    Product Code
    ETS
    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
    ETS Generator, Electronic Noise (For Audiometric Testing)

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