BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BRAINSCOPE

    Reg #: 3008660657 · FEI: 3008660657 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    BRAINSCOPE
    Registration Number
    3008660657
    FEI Number
    3008660657
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7648 Standish Place
    City
    Rockville
    State
    MD
    ZIP
    20855
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161068

    Owner / Operator

    Firm Name
    BrainScope Company, Inc.
    Operator Number
    10039715
    Address
    7648 Standish Place
    City
    Rockville
    State
    MD
    Postal Code
    20855
    Country
    US
    Correspondent
    Leslie S Prichep

    Products

    Device Name Product Code
    Normalizing Quantitative Electroencephalograph Software OLU
    Computerized Cognitive Assessment Aid PKQ
    Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid PIW

    Proprietary Names

    BrainScope One Ahead® 300 BrainScope One (Model: Ahead 500)

    Establishment Types

    Manufacture Medical Device