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

    Ceribell Delirium Monitor System

    K Number: K251936 · Decision Dec 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    13
    Review Days
    167

    Basic Information

    Device Name
    Ceribell Delirium Monitor System
    K Number
    K251936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1440
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ceribell, Inc.
    Date Received
    June 24, 2025
    Decision Date
    December 8, 2025
    Product Code
    NCG
    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
    NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

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