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

    GAMBRO PRESSURE MONITOR PRM 10

    K Number: K822822 · Decision Oct 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    86
    Review Days
    28

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    Basic Information

    Device Name
    GAMBRO PRESSURE MONITOR PRM 10
    K Number
    K822822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Gambro, Inc.
    Date Received
    September 20, 1982
    Decision Date
    October 18, 1982
    Product Code
    DXS
    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
    DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

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