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

    SHILEY OXYGENATOR THERMISTOR PROBE

    K Number: K810647 · Decision Apr 3, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    174
    Review Days
    23

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    Basic Information

    Device Name
    SHILEY OXYGENATOR THERMISTOR PROBE
    K Number
    K810647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Shiley, Inc.
    Date Received
    March 11, 1981
    Decision Date
    April 3, 1981
    Product Code
    DWC
    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
    DWC Controller, Temperature, Cardiopulmonary Bypass

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