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

    UROSKOP D1, UROSKOP D2, AND UROSKOP D3

    K Number: K923049 · Decision Sep 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    300
    Applicant Total
    519
    Review Days
    83

    Basic Information

    Device Name
    UROSKOP D1, UROSKOP D2, AND UROSKOP D3
    K Number
    K923049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Received
    June 24, 1992
    Decision Date
    September 15, 1992
    Product Code
    OWB
    Advisory Committee
    Radiology
    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
    OWB Interventional Fluoroscopic X-Ray System

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