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

    CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300

    K Number: K871221 · Decision Jun 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
    K Number
    K871221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    March 27, 1987
    Decision Date
    June 5, 1987
    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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    Other Clearances by Cardiovascular Devices, Inc.

    K Number Device Name
    K890113 THE CDI(R) SYSTEM 400
    K884228 CDI(R) 2000 BLOOD GAS MONITOR
    K864703 MODIFIED GAS-STAT(TM) MONITORING SYSTEM
    K843912 INTRAVASCULAR BLOOD GAS SYSTEM
    K840749 GAST STAT MONITORING SYSTEM
    K831225 GAS-STAT MONITORING SYSTEM
    K822000 EXTRACORPOREAL BLOOD GAS SYSTEM