FDA Clears Neuroelectrics Enobio Dx EEG Systems
The FDA cleared Neuroelectrics Barcelona's Enobio Dx line, in 8-, 20- and 32-channel models, on June 13, 2026, finding it substantially equivalent under submission number K261604 through the special 510(k) pathway. The agency classifies it as a Full-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Neuroelectrics is known in neuromodulation and BCI research for noninvasive EEG acquisition and transcranial electrical stimulation hardware.