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

    WIDEXLINK IN CLEAR SERIES HEARING AIDS

    K Number: DEN100025 · Decision Mar 31, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    169

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    Basic Information

    Device Name
    WIDEXLINK IN CLEAR SERIES HEARING AIDS
    K Number
    DEN100025
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    874.3305
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Office Research IN Clinical Amplifiction
    Date Received
    October 13, 2010
    Decision Date
    March 31, 2011
    Product Code
    OSM
    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
    OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription