BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    UNOMETER 500

    K Number: K896732 · Decision Nov 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    337

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    Basic Information

    Device Name
    UNOMETER 500
    K Number
    K896732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Unoplast A/S
    Date Received
    November 30, 1989
    Decision Date
    November 2, 1990
    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 Unoplast A/S

    K Number Device Name
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    K896733 VACCON
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