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

    RIMECO MIDSTREAM URINE COLLECTOR

    K Number: K943752 · Decision Nov 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    91

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    Basic Information

    Device Name
    RIMECO MIDSTREAM URINE COLLECTOR
    K Number
    K943752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rimeco Products, Inc.
    Date Received
    August 2, 1994
    Decision Date
    November 1, 1994
    Product Code
    FOC
    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
    FOC Bag, Urine Collection, Newborn

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