Neuralynx, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3009391672	3009391672	Neuralynx, Inc.	1	N	2026-01-01	105 Commercial Dr Bozeman MT US 59715

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850011306291	High Density Tether 7.5m - The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System. (7.5 meter)	4065854542	support@neuralynx.com
00850011306307	Tether Extension Cable Male-to-Male 3m - The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.	4065854542	support@neuralynx.com

neuralynx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
134755	1644372613	K250094	Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)	GYC	2025-04-14
134755	1920623111	K110967	ENTERPRISE ELECTROPHYSIOLOGY SYSTEM	OMC	2011-06-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GYC	1	2025-04-14
OMC	1	2011-06-30

PMN#

Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Softwar

2025-04-14

Neuralynx, Inc.

ENTERPRISE ELECTROPHYSIOLOGY SYSTEM

2011-06-30

NEURALYNX INC

GUDID#

ATLAS Cart - Dual Monitors - The ATLAS Cart is a mobile accessory cart intended to support and position system components (including monitors) for use with a cleared neurophysiology system.

NEURALYNX, INC.

2026-04-27

High Density Tether 7.5m - The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System. (7.5 meter)

NEURALYNX, INC.

2026-02-19

Tether Extension Cable Male-to-Male 3m - The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2026-02-19

ATLAS Stim Headbox - Touchproof - ATLAS Stim Headbox with Touchproof side panel.

NEURALYNX, INC.

2025-06-11

ATLAS Stim Headbox - High Density - ATLAS Stim Headbox with High Density side panel.

NEURALYNX, INC.

2025-06-11

ATLAS Stim Headbox Software - Control software for the ATLAS Stim Headbox.

NEURALYNX, INC.

2025-06-11

Fiber Optic Connector 2m - Computer ethernet connection; 2m in length.

NEURALYNX, INC.

2025-06-11

Fiber Optic Connector 7m - Computer ethernet connection; 7m in length.

NEURALYNX, INC.

2025-06-11

ATLAS Headbox Interface Cable - Touchproof - Cable to connect 100-pin Hirose connector to Touchproof pins.

NEURALYNX, INC.

2025-06-11

ATLAS Headbox Interface Cable - NK - Cable to connect 100-pin Hirose connector to NK connector.

NEURALYNX, INC.

2025-06-11

ATLAS Headbox Interface Cable - High Density - Cable to connect 100-pin Hirose connector to Natus connector.

NEURALYNX, INC.

2025-06-11

ATLAS Stim Headbox - NK - ATLAS Stim Headbox with Nihon Kohden passive side panel.

NEURALYNX, INC.

2025-06-11

ATLAS Headbox Expansion Panel - The ATLAS Headbox Expansion Panel is an accessory to the ATLAS Neurophysiology System and ATLAS Stim Headbox. The HEP is a power module and a signal splitter.

NEURALYNX, INC.

2022-11-10

Zipshield 8m - This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.

NEURALYNX, INC.

2024-12-11

ATLAS Workstation Monitor - The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).

NEURALYNX, INC.

2024-12-18

ATLAS Workstation - The ATLAS Workstation is a computer that runs the Data Acquisition Software.

NEURALYNX, INC.

2024-12-18

ATLAS Parallel TTL Cable - The Parallel TTL Cable is a ribbon cable that connects 25 pin computer parallel port to the digital I/O port on the ATLAS System, for the purpose of sending and receiving signals.

NEURALYNX, INC.

2024-12-18

ATLAS Rackmounted Power Isolator - An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level in a rack mounted form factor.

NEURALYNX, INC.

2024-12-11

Ethernet Switch - The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.

NEURALYNX, INC.

2024-12-11

Zipshield 5m - This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.

NEURALYNX, INC.

2024-12-11

ATLAS Power Isolator 110VAC - An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level.

NEURALYNX, INC.

2024-12-11

ATLAS Power Isolator 220VAC - An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level.

NEURALYNX, INC.

2024-12-11

DIXI Adapter - The DIXI Adapter allows customers to use 4 electrode microwire tails (8 channels per tail) and record those 32 channels to a single ATLAS Combo board.

NEURALYNX, INC.

2024-12-09

NetCom Client - NetCom Client is an application programming interface (API) that is intended to allow data transfer to/from the Pegasus software.

NEURALYNX, INC.

2022-11-10

Pegasus Software License 32ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 64ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 96ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 128ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 160ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 192ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 224ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 256ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 288ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 320ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 352ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 384ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 416ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 448ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 480ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

Pegasus Software License 512ch - The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.

NEURALYNX, INC.

2024-11-21

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