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

    COCHLEAR BAHA BP100

    K Number: K090720 · Decision Jun 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    COCHLEAR BAHA BP100
    K Number
    K090720
    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
    March 18, 2009
    Decision Date
    June 17, 2009
    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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    Other Clearances by Cochlear Bone Anchored Systems AB

    K Number Device Name
    K080363 BAHA CORDELLE II