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

    TM-5 INTRACRANIAL PRESSURE MONITOR

    K Number: K802149 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    26
    Review Days
    65

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    Basic Information

    Device Name
    TM-5 INTRACRANIAL PRESSURE MONITOR
    K Number
    K802149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Nicolet Biomedical Instruments
    Date Received
    September 8, 1980
    Decision Date
    November 12, 1980
    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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