ATLAS Ground Drive 31-0604-0100

GUDID 00850011306185

The Active Ground Drive generates the Active Ground signal based on input selected in the Data Acquisition Software.

NEURALYNX, INC.

Electroencephalographic monitoring system, stationary
Primary Device ID00850011306185
NIH Device Record Key27a3fba4-68da-492d-9d77-0e2b4bef4bf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameATLAS Ground Drive
Version Model NumberActive Ground Drive
Catalog Number31-0604-0100
Company DUNS933200842
Company NameNEURALYNX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com
Phone406-585-4542
Emailsupport@neuralynx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011306185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMCReduced- Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-27
Device Publish Date2022-09-19

Devices Manufactured by NEURALYNX, INC.

00850011306338 - ATLAS Stim Headbox - Touchproof2025-06-19 ATLAS Stim Headbox with Touchproof side panel.
00850011306345 - ATLAS Stim Headbox - High Density2025-06-19 ATLAS Stim Headbox with High Density side panel.
00850011306703 - ATLAS Stim Headbox Software2025-06-19 Control software for the ATLAS Stim Headbox.
00850011306710 - Fiber Optic Connector 2m2025-06-19 Computer ethernet connection; 2m in length.
00850011306727 - Fiber Optic Connector 7m2025-06-19 Computer ethernet connection; 7m in length.
00850011306901 - ATLAS Headbox Interface Cable - Touchproof2025-06-19 Cable to connect 100-pin Hirose connector to Touchproof pins.
00850011306918 - ATLAS Headbox Interface Cable - NK2025-06-19 Cable to connect 100-pin Hirose connector to NK connector.
00850011306925 - ATLAS Headbox Interface Cable - High Density2025-06-19 Cable to connect 100-pin Hirose connector to Natus connector.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.