Enobio Wireless EEG— 510(k) K162681

Name: FDA 510(k) clearance K162681
Creator: U.S. Food and Drug Administration
Published: 2017-06-02

Substantially Equivalent

Neuroelectrics Barcelona S.L.U.

FDA 510(k) clearance K162681 for Enobio Wireless EEG, Substantially Equivalent on 2017-06-02. Applicant: Neuroelectrics Barcelona S.L.U.. Device class: 2.

Clearance details

Applicant: Neuroelectrics Barcelona S.L.U.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2016-09-26
Decision date: 2017-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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