BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ceribell EEG Recorder with Clarity

    Reg #: 3013671918 · FEI: 3013671918 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CERIBELL, INC.
    Registration Number
    3013671918
    FEI Number
    3013671918
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    360 N Pastoria Ave
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191301

    Owner / Operator

    Firm Name
    Ceribell, Inc.
    Operator Number
    10055114
    Address
    360 N Pastoria Ave
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Raymond Woo

    Products

    Device Name Product Code
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Full-Montage Standard Electroencephalograph GWQ
    Reduced- Montage Standard Electroencephalograph OMC

    Proprietary Names

    Ceribell EEG Recorder with Clarity

    Establishment Types

    Manufacture Medical Device