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

    IN-LINE OXYGEN MONITORING SYSTEM

    K Number: K821159 · Decision May 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    56
    Review Days
    33

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    Basic Information

    Device Name
    IN-LINE OXYGEN MONITORING SYSTEM
    K Number
    K821159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    April 22, 1982
    Decision Date
    May 25, 1982
    Product Code
    DRY
    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
    DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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