ATLAS Workstation 31-0004-0000

GUDID 00850011306949

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

NEURALYNX, INC.

Electroencephalographic monitoring system

• Primary Device ID: 00850011306949
• NIH Device Record Key: 99b633fa-2392-4a14-bb11-e9cdc657c3e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS Workstation
• Version Model Number: ATLAS Workstation
• Catalog Number: 31-0004-0000
• Company DUNS: 933200842
• Company Name: NEURALYNX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110967

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

Devices Manufactured by NEURALYNX, INC.

• 00850011306338 - ATLAS Stim Headbox - Touchproof: 2025-06-19 ATLAS Stim Headbox with Touchproof side panel.
• 00850011306345 - ATLAS Stim Headbox - High Density: 2025-06-19 ATLAS Stim Headbox with High Density side panel.
• 00850011306703 - ATLAS Stim Headbox Software: 2025-06-19 Control software for the ATLAS Stim Headbox.
• 00850011306710 - Fiber Optic Connector 2m: 2025-06-19 Computer ethernet connection; 2m in length.
• 00850011306727 - Fiber Optic Connector 7m: 2025-06-19 Computer ethernet connection; 7m in length.
• 00850011306901 - ATLAS Headbox Interface Cable - Touchproof: 2025-06-19 Cable to connect 100-pin Hirose connector to Touchproof pins.
• 00850011306918 - ATLAS Headbox Interface Cable - NK: 2025-06-19 Cable to connect 100-pin Hirose connector to NK connector.
• 00850011306925 - ATLAS Headbox Interface Cable - High Density: 2025-06-19 Cable to connect 100-pin Hirose connector to Natus connector.