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

    CAPIOX LEVEL ALARM

    K Number: K915337 · Decision Feb 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    143
    Review Days
    87

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    Basic Information

    Device Name
    CAPIOX LEVEL ALARM
    K Number
    K915337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Terumo Medical Corp.
    Date Received
    November 26, 1991
    Decision Date
    February 21, 1992
    Product Code
    DTW
    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
    DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

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