Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)— 510(k) K261604

Substantially Equivalent

Neuroelectrics Barcelona S.L.U.

FDA 510(k) clearance K261604 for Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32), Substantially Equivalent on 2026-06-13. Applicant: Neuroelectrics Barcelona S.L.U..

Clearance details

Applicant
Neuroelectrics Barcelona S.L.U.
Product code
Code GWQ
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Barcelona, ES
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Data sourced from openFDA. This site is unofficial and independent of the FDA.