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

    BML SERIES

    K Number: K903529 · Decision Jan 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    142
    Review Days
    170

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    Basic Information

    Device Name
    BML SERIES
    K Number
    K903529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Olympus Corp.
    Date Received
    August 6, 1990
    Decision Date
    January 23, 1991
    Product Code
    LQC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQC Lithotriptor, Biliary Mechanical

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