BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OPUS 2 - CANAL SERIES (ITC)

    K Number: K974069 · Decision Dec 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    1366
    Applicant Total
    9
    Review Days
    48

    Basic Information

    Device Name
    OPUS 2 - CANAL SERIES (ITC)
    K Number
    K974069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BERNAFON-MAICO, INC.
    Date Received
    October 28, 1997
    Decision Date
    December 15, 1997
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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