Data / Medical devices / Israel / Firefly Neuroscience
Firefly Neuroscience: FDA-registered device maker in Hod Ha-Sharon Central, Israel, 2 510(k) clearances
Firefly Neuroscience is registered with the FDA (registration 3010376446) in Hod Ha-Sharon Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 7, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010376446
- Address
- 46, Sokolov, Hod Ha-Sharon Central, Israel, 4528475
- Owner or operator
- Firefly Neuroscience (10047445)
- Roles
- Manufacturer
- First device listed
- September 4, 2014
- Registered through
- 2026
- Brand names listed
- BNA, BNA Analysis System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Normalizing Quantitative Electroencephalograph Software | OLU | 2 | Manufacturer | 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 7, 2020 | K202588 | BNA Platform | OLU | Substantially Equivalent | Elminda, Ltd. | accessdata.fda.gov |
| July 25, 2014 | K121119 | BNA ANALYSIS SYSTEM | OLU | Substantially Equivalent | Eiminda , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 7, 2020. 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.