Enobio Dx (3 models)— 510(k) K261604
Substantially EquivalentNeuroelectrics Barcelona S.L.U.
FDA 510(k) clearance K261604 for Enobio Dx (3 models), Substantially Equivalent on 2026-06-13. Applicant: Neuroelectrics Barcelona S.L.U.. Device class: 2.
Summary
Neuroelectrics Barcelona's Enobio Dx is listed in three versions: Enobio Dx 8, Enobio Dx 20, and Enobio Dx 32. It's filed under GWQ, full-montage standard electroencephalographs, and the record doesn't say what the numbers refer to.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and it came in as a Special 510(k).
Neuroelectrics filed from Barcelona, Spain. Review took 30 calendar days (May 14 to June 13, 2026).
Clearance details
- Device name as filed
- Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
- Applicant
- Neuroelectrics Barcelona S.L.U.
- Product code
- Product code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Barcelona, ES
Recent devices under product code GWQ
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