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

    CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

    K Number: K232890 · Decision Feb 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
    K Number
    K232890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Production Corporation
    Date Received
    September 18, 2023
    Decision Date
    February 4, 2024
    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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