Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
K-Number: K261604 · 2026-06-13
Device Summary
Frequently Asked Questions
What is the Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)?
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) is a medical device that received FDA 510(k) clearance on 2026-06-13. The listed applicant is Neuroelectrics Barcelona S.L.U.. The 510(k) number is K261604.
When did Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) receive FDA 510(k) clearance?
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) received FDA 510(k) clearance on 2026-06-13, under 510(k) number K261604.
Who is the listed applicant for Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)?
The FDA 510(k) record lists Neuroelectrics Barcelona S.L.U. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)?
The FDA product code for Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) is GWQ.
Other records listing Neuroelectrics Barcelona S.L.U. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GWQ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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