Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

K261604 is the FDA 510(k) clearance record for Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32), a class II device, cleared for Neuroelectrics Barcelona S.L.U. on 2026-06-13 under FDA product code GWQ (Full-Montage Standard Electroencephalograph). FDA's definition for product code GWQ reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations". FDA records list 2 510(k) clearances for Neuroelectrics Barcelona S.L.U., from 2017-06-02 to 2026-06-13. As of 2026-09-10, FDA records show no recalls naming K261604.