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

    STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR

    K Number: K843802 · Decision Dec 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    174
    Review Days
    91

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    Basic Information

    Device Name
    STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
    K Number
    K843802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Shiley, Inc.
    Date Received
    September 27, 1984
    Decision Date
    December 27, 1984
    Product Code
    DTW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

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