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

    BAHA CORDELLE II

    K Number: K080363 · Decision Apr 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    BAHA CORDELLE II
    K Number
    K080363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cochlear Bone Anchored Systems AB
    Date Received
    February 11, 2008
    Decision Date
    April 10, 2008
    Product Code
    MAH
    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
    MAH Hearing Aid, Bone Conduction, Implanted

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    Other Clearances by Cochlear Bone Anchored Systems AB

    K Number Device Name
    K090720 COCHLEAR BAHA BP100