K250601
- 510(k) number
- K250601
- Device name
- Neuro Omega System; NeuroSmart System
- Applicant
- Alpha Omega Engineering , Ltd. IL
- Product code
- GZL — Electrode, Depth
- Decision date
- 2025-03-30
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250601.pdf
Official FDA record: K250601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.