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

    PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)

    K Number: K091786 · Decision Jun 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    5
    Review Days
    366

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    Basic Information

    Device Name
    PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
    K Number
    K091786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulsion Medical Systems AG
    Date Received
    June 17, 2009
    Decision Date
    June 18, 2010
    Product Code
    DXG
    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
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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    Other Clearances by Pulsion Medical Systems AG

    K Number Device Name
    K072735 PULSION PICCO-2, MODEL 8500
    K072364 PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
    K060898 PULSION PICCO PLUS, MODEL 8100
    K020587 PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046