FDA 510(k)

NeuroEEG

K-Number: K173460 · 2018-02-16

Decision Date2018-02-16

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NeuroEEG is the device name listed in this FDA 510(k) record. The listed applicant is Memory MD, Inc.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K173460. 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 NeuroEEG?

NeuroEEG is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Memory MD, Inc.. The 510(k) number is K173460.

When did NeuroEEG receive FDA 510(k) clearance?

NeuroEEG received FDA 510(k) clearance on 2018-02-16, under 510(k) number K173460.

Who is the listed applicant for NeuroEEG?

The FDA 510(k) record lists Memory MD, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroEEG?

The FDA product code for NeuroEEG is GWQ.

Other records listing Memory MD, Inc. 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.

K202913NeuroCap (Model DEC22)K172866NeuroCap

Related Devices (Code: GWQ)

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

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