BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CARDIAN III CR6A

    K Number: K864704 · Decision Mar 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    8
    Review Days
    108

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    Basic Information

    Device Name
    CARDIAN III CR6A
    K Number
    K864704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Recorders, Ltd.
    Date Received
    December 2, 1986
    Decision Date
    March 20, 1987
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Cardiac Recorders, Ltd.

    K Number Device Name
    K861621 CARDIAN II CR45A
    K853673 CARDIORATER CR 51
    K852910 CARDIORATER CR7
    K852887 CR5 CARDIAC MONITOR
    K852905 CR 280/45, CR281/4 DEFIBRILLATOR
    K852799 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
    K852808 CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)