Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009391672

FEI Number

3009391672

Entity Name

Neuralynx, Inc.

City/State/Country

Bozeman, MT, US

Establishment Address

105 Commercial Dr, Bozeman, MT 59715, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Neuralynx, Inc. (Owner Number: 10038712)

Owner / Operator Contact Address

105 Commercial Drive, Bozeman, MT 59715, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250094

PMA Number

N/A

All Registered Proprietary Names

ATLAS Neurophysiology System Atlas Stim Headbox (HD) Atlas Headbox Interface Cable (NK) Atlas Headbox Expansion Panel ATLAS Stim Headbox Software Atlas Headbox Interface Cable (Touchproof) Atlas Stim Headbox (Touchproof) ATLAS Stim Headbox (NK) ASHB FIBER OPTIC DUPLEX CONN 2m Atlas Headbox Interface Cable (HD) ASHB FIBER OPTIC DUPLEX CONN 7m

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2011-11-04
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2025-04-15

Official Correspondent

Kelly Moeykens

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neuralynx, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009391672. Last updated year: 2026. Please use registration number 3009391672 when referencing this establishment in official correspondence.