Data / Medical devices / Finland / Neuro Event Labs OY
Neuro Event Labs OY: FDA-registered device maker in Tampere Pirkanmaa, Finland, 1 510(k) clearance
Neuro Event Labs OY is registered with the FDA (registration 3022175264) in Tampere Pirkanmaa, Finland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022175264
- Address
- Biokatu 10, Tampere Pirkanmaa, Finland, 33520
- Owner or operator
- Neuro Event Labs Oy (10094789)
- Roles
- Manufacturer
- First device listed
- December 23, 2025
- Registered through
- 2026
- Brand names listed
- Nelli
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Physiological Signal Based Seizure Monitoring System | POS | 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 |
|---|---|---|---|---|---|---|
| November 21, 2025 | K251506 | Nelli (Version 7.11) | POS | Substantially Equivalent | Neuro Event Labs OY | accessdata.fda.gov |
Compare with other makers
Updated November 21, 2025. 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.