BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UROVIEW

    K Number: K872022 · Decision Jul 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    51

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    Basic Information

    Device Name
    UROVIEW
    K Number
    K872022
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4890
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Oec-Diasonics, Inc.
    Date Received
    May 26, 1987
    Decision Date
    July 16, 1987
    Product Code
    KQS
    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
    KQS Table, Cystometric, Non-Electric And Accessories

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    Other Clearances by Oec-Diasonics, Inc.

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    K926056 9600 FLUOROSCOPIC IMAGING SYSTEM
    K924879 EP 3000
    K914446 UROVIEW 2000, MODIFICATION
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    K893475 UROVIEW II
    K864837 MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM
    K843972 ANGIOPLUS-S