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

    AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT

    K Number: K130514 · Decision Nov 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    4
    Review Days
    267

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    Basic Information

    Device Name
    AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
    K Number
    K130514
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Audifon-USA, Inc.
    Date Received
    February 27, 2013
    Decision Date
    November 21, 2013
    Product Code
    KLW
    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
    KLW Masker, Tinnitus

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    Other Clearances by Audifon-USA, Inc.

    K Number Device Name
    K130417 AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
    K121793 AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
    K083488 JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT