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

    FLOWMETER, OPTIFLO GAS

    K Number: K790546 · Decision May 11, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    77
    Review Days
    52

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    Basic Information

    Device Name
    FLOWMETER, OPTIFLO GAS
    K Number
    K790546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    March 20, 1979
    Decision Date
    May 11, 1979
    Product Code
    DTX
    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
    DTX Gas Control Unit, Cardiopulmonary Bypass

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