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

    PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046

    K Number: K020587 · Decision May 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
    K Number
    K020587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulsion Medical Systems AG
    Date Received
    February 22, 2002
    Decision Date
    May 23, 2002
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

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    Other Clearances by Pulsion Medical Systems AG

    K Number Device Name
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    K072735 PULSION PICCO-2, MODEL 8500
    K072364 PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
    K060898 PULSION PICCO PLUS, MODEL 8100