Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008857629

FEI Number

3008857629

Entity Name

FIREFLY NEUROSCIENCE, INC.

City/State/Country

New York, NY, US

Establishment Address

1115 Broadway Fl 12, New York, NY 10010, US

Establishment Type(s)

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

Owner / Operator

Firefly Neuroscience, Inc. (Owner Number: 10095851)

Owner / Operator Contact Address

1115 Broadway Fl 12, New York, NY 10010, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171781

PMA Number

N/A

All Registered Proprietary Names

Evoke EEG System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-11
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2026-05-11

Official Correspondent

Dave DeCaprio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Firefly Neuroscience, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008857629. Last updated year: 2026. Please use registration number 3008857629 when referencing this establishment in official correspondence.