Pegasus Pegasus

GUDID 00867718000278

Pegasus is the software component of the ATLAS Neurophysiology System that interfaces with the amplifier. It is used to display, store and archive EEG signals and allow user-only annotation and marking. Pegasus does not analyze EEG or automatically detect events.

NEURALYNX, INC.

Electroencephalographic monitoring system

• Primary Device ID: 00867718000278
• NIH Device Record Key: 09e4bf7a-64d5-4fe4-8586-9cff95330d1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pegasus
• Version Model Number: 2.3.1
• Catalog Number: Pegasus
• 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: true
• 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

Customer Support Contacts

• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com
• Phone: 406-585-4542
• Email: support@neuralynx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867718000278 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-07-12
• Device Publish Date: 2016-08-31

Devices Manufactured by NEURALYNX, INC.

• 00850011306932 - ATLAS Workstation Monitor: 2024-12-26 The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
• 00850011306949 - ATLAS Workstation: 2024-12-26 The ATLAS Workstation is a computer that runs the Data Acquisition Software.
• 00850011306956 - ATLAS Parallel TTL Cable: 2024-12-26 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
• 00850011306239 - ATLAS Rackmounted Power Isolator: 2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien
• 00850011306253 - Ethernet Switch: 2024-12-19 The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
• 00850011306963 - Zipshield 5m: 2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
• 00850011306970 - Zipshield 10m: 2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
• 00850011306987 - ATLAS Power Isolator 110VAC: 2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien