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

    CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA

    K Number: K922941 · Decision Aug 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    5
    Review Days
    69

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    Basic Information

    Device Name
    CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA
    K Number
    K922941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinical Neuro Systems, LLC
    Date Received
    June 18, 1992
    Decision Date
    August 26, 1992
    Product Code
    JXG
    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
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Clinical Neuro Systems, LLC

    K Number Device Name
    K961113 CNS INTERCHANGEABLE BIT CRANIAL DRILL
    K930229 CLINICAL NEURO SYSTEMS CRANIAL DRILL
    K922936 CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE
    K920156 CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY