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

    BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

    K Number: K040940 · Decision Apr 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    5
    Review Days
    7

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    Basic Information

    Device Name
    BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
    K Number
    K040940
    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
    Olympus Corporation
    Date Received
    April 12, 2004
    Decision Date
    April 19, 2004
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    Y

    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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