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

    COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)

    K Number: K962928 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    3
    Review Days
    144

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    Basic Information

    Device Name
    COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
    K Number
    K962928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Camino Neurocare, Inc.
    Date Received
    July 29, 1996
    Decision Date
    December 20, 1996
    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 Camino Neurocare, Inc.

    K Number Device Name
    K982702 VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
    K981846 PARENCHYMAL BOLT PRESSURE MONITORING KIT