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510(k) Data Aggregation

    K Number
    K254033

    Validate with FDA (Live)

    Device Name
    Ceribell Instant EEG Headset
    Manufacturer
    Ceribell, Inc.
    Date Cleared
    2026-02-09

    (55 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Abbreviated
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K232052,K223086
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ceribell Instant EEG Headset is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

    Device Description

    The Ceribell Instant EEG Headset is a single-use, non-sterile, disposable EEG electrode device that includes up to 20 EEG electrodes that are placed on the subject's scalp. The headset is a prescription-use device intended to collect and provide EEG signals to an EEG recording or monitoring device.

    The Ceribell Instant EEG Headset includes the following components:

    • Elastic fabric headset
    • Electrode assemblies, each consisting of the following:
      • Passive silver/silver chloride (Ag/AgCl) electrode
      • Reservoir filled with conductive electrolyte gel
    • Mechanism for dispensing gel onto patient scalp
    • Scalp-contacting prongs to prepare scalp for electrode contact
    • Cable attached to the headset to allow connection to an EEG acquisition/recording device
    AI/ML Overview

    N/A

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