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

    LAWRENCE L3000 CARDIAC OUTPUT MONITOR

    K Number: K874885 · Decision Feb 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    4
    Review Days
    66

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    Basic Information

    Device Name
    LAWRENCE L3000 CARDIAC OUTPUT MONITOR
    K Number
    K874885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Lawrence Medical Systems, Inc.
    Date Received
    December 1, 1987
    Decision Date
    February 5, 1988
    Product Code
    DPW
    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
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Lawrence Medical Systems, Inc.

    K Number Device Name
    K874492 LAWRENCE L4000 REFLECTANCE PULSE OXIMETER
    K862548 TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
    K851426 ACCUCOM CARDIAC OUTPUT MONITOR