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

    MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2

    K Number: K071473 · Decision Jul 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    10
    Review Days
    44

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    Basic Information

    Device Name
    MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
    K Number
    K071473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Superdimension, Ltd.
    Date Received
    May 29, 2007
    Decision Date
    July 12, 2007
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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