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

    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM

    K Number: K020967 · Decision Jun 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    43
    Review Days
    87

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    Basic Information

    Device Name
    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
    K Number
    K020967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1170
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corp.
    Date Received
    March 25, 2002
    Decision Date
    June 20, 2002
    Product Code
    CBZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

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    K130359 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
    K123039 CDI BLOOD PARAMETER MONITORING SYSTEM 500
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