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

    Bose Hearing Aid

    K Number: DEN180026 · Decision Oct 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    147

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    Basic Information

    Device Name
    Bose Hearing Aid
    K Number
    DEN180026
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.3325
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Bose Corporation
    Date Received
    May 11, 2018
    Decision Date
    October 5, 2018
    Product Code
    QDD
    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
    QDD Self-Fitting Air-Conduction Hearing Aid, Prescription

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    Other Clearances by Bose Corporation

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