BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    HOME URODATA SYSTEM(TM)

    K Number: K900770 · Decision Jun 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    15
    Applicant Total
    20
    Review Days
    112

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    Basic Information

    Device Name
    HOME URODATA SYSTEM(TM)
    K Number
    K900770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Biodan Medical Systems, Ltd.
    Date Received
    February 16, 1990
    Decision Date
    June 8, 1990
    Product Code
    EXY
    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
    EXY Uroflowmeter

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