BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    GR100F URINE FLOWMETER

    K Number: K971913 · Decision Sep 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    120

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    Basic Information

    Device Name
    GR100F URINE FLOWMETER
    K Number
    K971913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Albyn Medical , Ltd.
    Date Received
    May 22, 1997
    Decision Date
    September 19, 1997
    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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