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510(k) K261604

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) by Neuroelectrics Barcelona S.L.U. — Product Code GWQ

K261604 is an FDA 510(k) premarket notification submitted by Neuroelectrics Barcelona S.L.U. for the device "Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)". The FDA issued a decision of Substantially Equivalent on June 13, 2026. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Neuroelectrics Barcelona S.L.U. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2026
Date Received
May 14, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

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

Other clearances by Neuroelectrics Barcelona S.L.U.

  • K162681 — Enobio Wireless EEG (June 2, 2017)

Other clearances for product code GWQ

  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)
  • K212788 — Seer Home (June 16, 2022)

FDA data resources