Pegasus Software License 160ch 36-0301-0034

GUDID 00850011306789

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.

Electroencephalographic monitoring system

• Primary Device ID: 00850011306789
• NIH Device Record Key: 20137921-cc0f-45aa-ab11-1792e6d3e883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pegasus Software License 160ch
• Version Model Number: 160 Channel
• Catalog Number: 36-0301-0034
• 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: false
• Manufacturing Date: false
• 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	00850011306789 [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: 2024-11-29
• Device Publish Date: 2024-11-21

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.