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

    COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)

    K Number: K900910 · Decision May 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    77
    Review Days
    84

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    Basic Information

    Device Name
    COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
    K Number
    K900910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    February 27, 1990
    Decision Date
    May 22, 1990
    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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