Pegasus Software License 32ch 36-0301-0030

GUDID 00850011306741

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 ID00850011306741
NIH Device Record Keybebcf1b7-53e8-4eb0-bf98-b3c80bedb30a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePegasus Software License 32ch
Version Model Number32 channel
Catalog Number36-0301-0030
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011306741 [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 Date2024-11-29
Device Publish Date2024-11-21

Devices Manufactured by NEURALYNX, INC.

00850011306932 - ATLAS Workstation Monitor2024-12-26 The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
00850011306949 - ATLAS Workstation2024-12-26 The ATLAS Workstation is a computer that runs the Data Acquisition Software.
00850011306956 - ATLAS Parallel TTL Cable2024-12-26 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 Isolator2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien
00850011306253 - Ethernet Switch2024-12-19 The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
00850011306963 - Zipshield 5m2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
00850011306970 - Zipshield 10m2024-12-19 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 110VAC2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien

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