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

    PERFUSION MONITOR

    K Number: K900860 · Decision Aug 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    23
    Review Days
    172

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    Basic Information

    Device Name
    PERFUSION MONITOR
    K Number
    K900860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4410
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardio Metrics, Inc.
    Date Received
    February 23, 1990
    Decision Date
    August 14, 1990
    Product Code
    DTY
    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
    DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

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