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510(k) Data Aggregation

    K Number
    K251381
    Device Name
    Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
    Manufacturer
    Ceribell, Inc.
    Date Cleared
    2025-10-31

    (182 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Abbreviated
    Panel
    Neurology
    Reference & Predicate Devices
    K223086
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies.

    Device Description

    The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.

    The Ceribell Headcap includes the following components:

    • An elastic fabric headcap
    • An elastic fabric chin strap
    • Nine (9) silver/silver chloride (Ag/AgCl) electrodes
    • A cable attached to the headcap to allow connection to an EEG acquisition/recording device
    AI/ML Overview

    N/A

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