BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NEUROSENSOR

    K Number: K013930 · Decision Feb 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    NEUROSENSOR
    K Number
    K013930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novus Monitoring, Ltd.
    Date Received
    November 28, 2001
    Decision Date
    February 20, 2002
    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 Novus Monitoring, Ltd.

    K Number Device Name
    K042728 CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM