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

    LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.

    K Number: K863535 · Decision Jan 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    23
    Review Days
    117

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    Basic Information

    Device Name
    LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
    K Number
    K863535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Computerized Medical Systems, Inc.
    Date Received
    September 11, 1986
    Decision Date
    January 6, 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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