Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011184129

FEI Number

3011184129

Entity Name

NEURONETRIX SOLUTIONS, LLC

City/State/Country

Louisville, KY, US

Establishment Address

1044 E Chestnut St Ste 8, Louisville, KY 40204, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neuronetrix Solutions, LLC (Owner Number: 10048856)

Owner / Operator Contact Address

1044 E Chestnut Street, Suite 8, Louisville, KY 40204, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141316

PMA Number

N/A

All Registered Proprietary Names

GWJ / STIMULATOR, AUDITORY, EVOKED RESPONSE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2015-03-11
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2015-03-11
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-03-11

Official Correspondent

Kalford Fadem

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neuronetrix Solutions, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011184129. Last updated year: 2026. Please use registration number 3011184129 when referencing this establishment in official correspondence.