FDA 510(k)

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

K号: K261604 · 2026-06-13

决定日期2026-06-13

产品代码GWQ

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决定实质等同

器械摘要

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) is the device name listed in this FDA 510(k) record. The listed applicant is Neuroelectrics Barcelona S.L.U.. It received FDA 510(k) clearance on 2026-06-13 under 510(k) number K261604. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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.

列明Neuroelectrics Barcelona S.L.U.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K162681Enobio 无线脑电图

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