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

    TINNITUS DEVICES

    K Number: K790064 · Decision Feb 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    32

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    Basic Information

    Device Name
    TINNITUS DEVICES
    K Number
    K790064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1120
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Vicon Instrument Co.
    Date Received
    January 15, 1979
    Decision Date
    February 16, 1979
    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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    K771762 MODULAR HEARING DEVICE, MODEL S291
    K770938 TINNITUS AID, MODEL S244
    K761216 HEARING AIDS (MODEL E-552 S-712)
    K760215 HEARING AID, S-522 FM