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

    HYPERSOUND AUDIO SYSTEM (HSS)

    K Number: K133352 · Decision Feb 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    HYPERSOUND AUDIO SYSTEM (HSS)
    K Number
    K133352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hypersound Health, Inc.
    Date Received
    October 31, 2013
    Decision Date
    February 12, 2014
    Product Code
    EPF
    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
    EPF Hearing Aid, Group And Auditory Trainer

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