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.
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
- 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
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