K233985
- 510(k) number
- K233985
- Device name
- TRIUX neo (NM27000N ); MEGreview (SW26241N-B)
- Applicant
- Megin OY FI
- Product code
- OLX — Source Localization Software For Electroencephalogra
- Decision date
- 2024-05-15
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233985.pdf
Official FDA record: K233985
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.