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

    OLYMPUS BF TYPE UM40

    K Number: K021204 · Decision May 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    22
    Review Days
    15

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    Basic Information

    Device Name
    OLYMPUS BF TYPE UM40
    K Number
    K021204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Optical Co., Ltd.
    Date Received
    April 16, 2002
    Decision Date
    May 1, 2002
    Product Code
    PSV
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    PSV Ultrasound Bronchoscope

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