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

    ULTRACOMPACT

    K Number: K894968 · Decision Nov 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    ULTRACOMPACT
    K Number
    K894968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Eutectic Electronics, Inc.
    Date Received
    August 7, 1989
    Decision Date
    November 8, 1989
    Product Code
    EXY
    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
    EXY Uroflowmeter

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