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

    BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM

    K Number: K093650 · Decision Feb 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    209
    Review Days
    84

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    Basic Information

    Device Name
    BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
    K Number
    K093650
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4410
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    November 25, 2009
    Decision Date
    February 17, 2010
    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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