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

    UROSTAT

    K Number: K854539 · Decision Feb 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    UROSTAT
    K Number
    K854539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.2040
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Urologics, Inc.
    Date Received
    November 13, 1985
    Decision Date
    February 4, 1986
    Product Code
    KPN
    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
    KPN Alarm, Conditioned Response Enuresis

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    Other Clearances by Urologics, Inc.

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