BCIwiki (bciwiki.com) — Neuroelectrics Barcelona S.L.U. received an FDA 510(k) decision of Substantially Equivalent for Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) on June 13, 2026, under submission number K261604. The submission followed the Special 510(k) clearance pathway.
FDA lists the product under the device classification name Full-Montage Standard Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Neuroelectrics is known in neuromodulation and BCI research for noninvasive EEG acquisition and transcranial electrical stimulation hardware; the cleared Enobio Dx line comes in 8, 20 and 32 channel configurations.