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

    MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

    K Number: K102077 · Decision Jan 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    4
    Review Days
    175

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    Basic Information

    Device Name
    MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    K Number
    K102077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cma Microdialysis AB
    Date Received
    July 23, 2010
    Decision Date
    January 14, 2011
    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
    K071984 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    K060554 CMA CEREBRAL TISSUE MONITORING SYSTEM
    K020285 CMA CEREBRAL TISSUE MONITORING SYSTEM