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

    BAHA 3 POWER SOUND PROCESSOR

    K Number: K110996 · Decision May 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    48
    Applicant Total
    10
    Review Days
    29

    Basic Information

    Device Name
    BAHA 3 POWER SOUND PROCESSOR
    K Number
    K110996
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COCHLEAR AMERICAS
    Date Received
    April 11, 2011
    Decision Date
    May 10, 2011
    Product Code
    LXB
    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
    LXB Hearing Aid, Bone Conduction

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