BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FIREFLY NEUROSCIENCE, INC.

    Reg #: 3008857629 · FEI: 3008857629 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    2

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    Registration Details

    Registration Name
    FIREFLY NEUROSCIENCE, INC.
    Registration Number
    3008857629
    FEI Number
    3008857629
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1115 Broadway Fl 12
    City
    New York
    State
    NY
    ZIP
    10010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171781

    Owner / Operator

    Firm Name
    Firefly Neuroscience, Inc.
    Operator Number
    10095851
    Address
    1115 Broadway Fl 12
    City
    New York
    State
    NY
    Postal Code
    10010
    Country
    US
    Correspondent
    Dave DeCaprio

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Stimulator, Auditory, Evoked Response GWJ

    Proprietary Names

    Evoke EEG System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility