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

    CARDIOBEEPER(R) III

    K Number: K880300 · Decision May 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    10
    Review Days
    108

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    Basic Information

    Device Name
    CARDIOBEEPER(R) III
    K Number
    K880300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Survival Technology, Inc.
    Date Received
    January 25, 1988
    Decision Date
    May 12, 1988
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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    K822093 STAT-SCAN
    K813101 CARDIOBEEPER MEMORY MONITOR
    K772178 PACER MONITOR, PULSE WIDTH