K251506
- 510(k) number
- K251506
- Device name
- Nelli (Version 7.11)
- Applicant
- Neuro Event Labs OY FI
- Product code
- POS — Physiological Signal Based Seizure Monitoring System
- Decision date
- 2025-11-21
- Date received
- 2025-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251506.pdf
Official FDA record: K251506
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.