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

    BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM

    K Number: K954501 · Decision Jan 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    13
    Review Days
    110

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    Basic Information

    Device Name
    BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
    K Number
    K954501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4410
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Bio-Medicus, Inc.
    Date Received
    September 28, 1995
    Decision Date
    January 16, 1996
    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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