BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPARK NEURO, INC.

    Reg #: 3029984080 · FEI: 3029984080 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SPARK NEURO, INC.
    Registration Number
    3029984080
    FEI Number
    3029984080
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    224 W 35th St Ste 500 # 2031
    City
    New York
    State
    NY
    ZIP
    10001
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231457

    Owner / Operator

    Firm Name
    Spark Neuro, Inc.
    Operator Number
    10089104
    Address
    212 W. 18th Street, 17a
    City
    New York
    State
    NY
    Postal Code
    10011
    Country
    US
    Correspondent
    Marinela Gombosev

    Products

    Device Name Product Code
    Computerized Cognitive Assessment Aid, Exempt PTY
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    SPARK Neuro Cognitive Assessment Aid SPARK Scan

    Establishment Types

    Manufacture Medical Device