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

    BARD URINE METER W/ BAG

    K Number: K761083 · Decision Jan 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    645
    Review Days
    68

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    Basic Information

    Device Name
    BARD URINE METER W/ BAG
    K Number
    K761083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    C.R. Bard, Inc.
    Date Received
    November 19, 1976
    Decision Date
    January 26, 1977
    Product Code
    EXR
    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
    EXR Urinometer, Mechanical

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