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

    URINE METER, 250CC

    K Number: K871042 · Decision Mar 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    8
    Review Days
    8

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    Basic Information

    Device Name
    URINE METER, 250CC
    K Number
    K871042
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Salt Creek Medical Technologies
    Date Received
    March 17, 1987
    Decision Date
    March 25, 1987
    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 Salt Creek Medical Technologies

    K Number Device Name
    K864683 NEONATAL FEEDING KIT
    K871075 SCMT UMBILICAL CLAMP
    K871087 S.C.M.T. PERFORATOR
    K864296 S.C.T. MULTI PORT, INJECTION SITE
    K864682 SALT CREEK P.I. TRAY
    K864692 EXTENSION SETS
    K864693 I.V. START KITS