FDA.reportPublic FDA data

Pegasus Software License 224ch

Primary DI
00850011306802
Brand
Pegasus Software License 224ch
Company
NEURALYNX, INC.
Model
224 Channel
Catalog number
36-0301-0036
Device description
The ATLAS Neurophysiology System is intended to be used for temporary (
Published
2024-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110967000ENTERPRISE ELECTROPHYSIOLOGY SYSTEMNeuralynx, Inc.2011-06-30OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011306802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011306802008500113068028500113068020850011306802

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933200842
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011306314ATLAS Cart - Dual Monitors31-0605-016931-0605-01692026-04-27
00850011306291High Density Tether 7.5m7.5 meter31-0202-00072026-02-19
00850011306307Tether Extension Cable Male-to-Male 3m3 meter31-0613-00312026-02-19
00850011306338ATLAS Stim Headbox - TouchproofTouchproof31-0601-00892025-06-11
00850011306345ATLAS Stim Headbox - High DensityHigh Density31-0601-01322025-06-11
00850011306703ATLAS Stim Headbox Software1.5.136-0301-00062025-06-11
00850011306710Fiber Optic Connector 2m2m31-0204-00012025-06-11
00850011306727Fiber Optic Connector 7m7m31-0204-00022025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofTouchproof31-0204-00042025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNK31-0204-00032025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityHigh Density31-0204-00052025-06-11
00867718000285ATLAS Stim Headbox - NKNK31-0601-00772025-06-11
00850011306512ATLAS Headbox Expansion PanelATLAS HEP31-0607-00142022-11-10
00850011306970Zipshield 8m8m31-0604-01292024-12-11
00850011306932ATLAS Workstation MonitorATLAS Workstation Monitor31-0000-00022024-12-18
00850011306949ATLAS WorkstationATLAS Workstation31-0004-00002024-12-18
00850011306956ATLAS Parallel TTL CableATLAS Parallel TTL Cable31-0602-00242024-12-18
00850011306239ATLAS Rackmounted Power IsolatorATLAS Rackmounted Power Isolator31-0607-00152024-12-11
00850011306253Ethernet SwitchEthernet Switch31-0604-01392024-12-11
00850011306963Zipshield 5m5m31-0604-01282024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011306314ATLAS Cart - Dual MonitorsNEURALYNX, INC.OMC2026-04-27
05999860882046QUEX EDQX WORLD LTDOMC2026-04-27
05999860882053QUEX SQX WORLD LTDOMC2026-04-27
05999860882060QUEX EDQX WORLD LTDOMC2026-04-27
05999860882077QUEX SQX WORLD LTDOMC2026-04-27
B566847020ZmachineGeneral SleepOMC2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOMC2026-04-15
B566847001ZmachineGeneral SleepOMC2026-04-09
B566847002ZmachineGeneral SleepOMC2026-04-09
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2026-03-18
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDOMC2026-03-12
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDOMC2026-01-23
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2025-12-22
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDOMC2025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2025-12-15
09357225002021Nurochek-Pro Application HEADSAFE MFG PTY LTDOMC2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDOMC2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDOMC2025-12-15
09357225006029Nurochek-Pro Saline SolutionHEADSAFE MFG PTY LTDOMC2025-12-15
B706H10000COGNISION EEG/EP SystemNeuronetrix Solutions, LLCOMC2025-03-12
00382830045100NatusXLTEKOMC2025-02-26
00382830045117NatusXLTEKOMC2025-02-26
00382830045391NatusXLTEKOMC2025-02-26