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

    CMA CEREBRAL TISSUE MONITORING SYSTEM

    K Number: K060554 · Decision May 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    4
    Review Days
    62

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    Basic Information

    Device Name
    CMA CEREBRAL TISSUE MONITORING SYSTEM
    K Number
    K060554
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cma Microdialysis AB
    Date Received
    March 1, 2006
    Decision Date
    May 2, 2006
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Cma Microdialysis AB

    K Number Device Name
    K102077 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    K071984 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    K020285 CMA CEREBRAL TISSUE MONITORING SYSTEM