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

    URINARY MONITORING SYS 240

    K Number: K840917 · Decision May 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    9
    Review Days
    61

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    Basic Information

    Device Name
    URINARY MONITORING SYS 240
    K Number
    K840917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vital Metrics, Inc.
    Date Received
    March 1, 1984
    Decision Date
    May 1, 1984
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by Vital Metrics, Inc.

    K Number Device Name
    K883201 VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS
    K882956 VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION
    K844973 IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES
    K843441 URINARY DRAINAGE CONTAINER 2012-WITH
    K843442 URINARY DRAINAGE CONTAINER 2013 WITH
    K834448 URINARY DRAINAGE CONTAINER
    K832526 UROTRACK PLUS
    K813641 VITAL METRICS URINE MONITORING SYSTEM