Data / Medical devices / Normalizing Quantitative Electroencephalograph Software
Normalizing Quantitative Electroencephalograph Software (OLU): 11 FDA-registered makers in 7 countries
11 establishments in 7 countries are registered with the FDA to make Normalizing Quantitative Electroencephalograph Software (product code OLU, Class 2, 21 CFR 882.1400). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 12, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- OLU
- Device class
- 2
- Regulation
- 882.1400
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Austria | 2 |
| Israel | 1 |
| Germany | 1 |
| South Korea | 1 |
| Bulgaria | 1 |
| Canada | 1 |
Makers of Normalizing Quantitative Electroencephalograph Software
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Firefly Neuroscience | Hod Ha-Sharon Central, Israel | Manufacturer | 2 | December 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Applied Neuroscience, Inc. | Redington Shores, FL, United States | Manufacturer | 1 | August 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Bee Medic GMBH | Bamberg Bavaria, Germany | Manufacturer | 1 | March 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| Brainmaster Technologies, Inc. | Bedford, OH, United States | Specification developer | 1 | July 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| G.tec Medical Engineering GMBH | Graz Steiermark, Austria | Manufacturer | 1 | January 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| G.tec Medical Engineering GMBH | SCHIEDLBERG Oberosterreich, Austria | Specification developer | 1 | January 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Imedisync Inc. | Gangnam-gu Seoul, South Korea | Manufacturer | 1 | March 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | Manufacturer | 1 | January 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Neurofield, Inc. | Santa Barbara, CA, United States | Complaint file establishment, Specification developer | 1 | September 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Voxneuro, Inc. | Toronto Ontario, Canada | Manufacturer | 1 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Brainscope | Rockville, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2026. 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.