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FDA 510(k)

EEG-Now

K-Number: K180524 · 2018-05-18

ApplicantEncephalodynamics, Inc.
Decision Date2018-05-18
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG-Now is a medical device manufactured by Encephalodynamics, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval number K180524. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG-Now?

EEG-Now is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Encephalodynamics, Inc.. The 510(k) number is K180524.

When was EEG-Now approved by the FDA?

EEG-Now received FDA 510(k) clearance on 2018-05-18, under approval number K180524.

What company makes EEG-Now?

EEG-Now is manufactured by Encephalodynamics, Inc..

What is the FDA product code for EEG-Now?

The FDA product code for EEG-Now is GXY.

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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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