510(k) K251366
K251366 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)". The FDA issued a decision of Substantially Equivalent on October 9, 2025. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2025
- Date Received
- May 1, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Normalizing Quantitative Electroencephalograph Software
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.