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FDA 510(k)

Enobio Wireless EEG

K-Number: K162681 · 2017-06-02

ApplicantNeuroelectrics Barcelona S.L.U.
Decision Date2017-06-02
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Enobio Wireless EEG is a medical device manufactured by Neuroelectrics Barcelona S.L.U.. It received FDA 510(k) clearance on 2017-06-02 under approval number K162681. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enobio Wireless EEG?

Enobio Wireless EEG is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by Neuroelectrics Barcelona S.L.U.. The 510(k) number is K162681.

When was Enobio Wireless EEG approved by the FDA?

Enobio Wireless EEG received FDA 510(k) clearance on 2017-06-02, under approval number K162681.

What company makes Enobio Wireless EEG?

Enobio Wireless EEG is manufactured by Neuroelectrics Barcelona S.L.U..

What is the FDA product code for Enobio Wireless EEG?

The FDA product code for Enobio Wireless EEG is GWQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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