Data / Medical devices / United States / Firefly Neuroscience, Inc.
Firefly Neuroscience, Inc.: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
Firefly Neuroscience, Inc. is registered with the FDA (registration 3008857629) in New York, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008857629
- Address
- 1115 Broadway Fl 12, New York, NY, United States, 10010
- Owner or operator
- Firefly Neuroscience, Inc. (10095851)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 11, 2026
- Registered through
- 2026
- Brand names listed
- Evoke EEG System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2017 | K171781 | eVox System | GWQ | Substantially Equivalent | Evoke Neuroscience, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Stimulator, Auditory, Evoked Response
Updated December 13, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.