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

    KENDALL PEDIATRIC URINE METER

    K Number: K911258 · Decision Apr 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    66
    Review Days
    34

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    Basic Information

    Device Name
    KENDALL PEDIATRIC URINE METER
    K Number
    K911258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    March 22, 1991
    Decision Date
    April 25, 1991
    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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    Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

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    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
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    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
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