BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    CARDIOBEEPER MEMORY MONITOR

    K Number: K813101 · Decision Nov 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    10
    Review Days
    24

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    Basic Information

    Device Name
    CARDIOBEEPER MEMORY MONITOR
    K Number
    K813101
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Survival Technology, Inc.
    Date Received
    November 3, 1981
    Decision Date
    November 27, 1981
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Survival Technology, Inc.

    K Number Device Name
    K925535 CARDIOBEEPER(R) CB-IIA
    K894799 CARDIOBEEPER MEMORY MONITOR CB 600 SERIES
    K890461 CARDIOBEEPER IV
    K883843 CARDIOBEEPER II
    K883614 CYTOGUARD(R)
    K880300 CARDIOBEEPER(R) III
    K844966 CARDIOBEEPER PROFILE MONITOR
    K822093 STAT-SCAN
    K772178 PACER MONITOR, PULSE WIDTH