K251366
- 510(k) number
- K251366
- Device name
- EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- Applicant
- Nihon Kohden Corporation JP
- Product code
- OLT — Non-Normalizing Quantitative Electroencephalograph S
- Decision date
- 2025-10-09
- Date received
- 2025-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251366.pdf
Official FDA record: K251366
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.