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

    STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR

    K Number: K900797 · Decision May 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    174
    Review Days
    79

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    Basic Information

    Device Name
    STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
    K Number
    K900797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Shiley, Inc.
    Date Received
    February 20, 1990
    Decision Date
    May 10, 1990
    Product Code
    DXS
    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
    DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

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