FDA.reportPublic FDA data

COGNISION EEG/EP System

Primary DI
B706H10000
Brand
COGNISION EEG/EP System
Company
Neuronetrix Solutions, LLC
Model
3000
Catalog number
H1000
Device description
COGNISION EEG/EP System. Includes headset, headset control unit, earphones, cables, and system case.
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K141316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141316000COGNISION EEG/EP SYSTEMNeuronetrix Solutions2015-02-13OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B706H10000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-561-9040support@cognision.com

Regulatory Flags#

DUNS number
117102035
Device count
1
DM exempt
true
Contains natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
00382830045100NatusXLTEKOMC2025-02-26
00382830045117NatusXLTEKOMC2025-02-26
00382830045391NatusXLTEKOMC2025-02-26
00382830045742NatusXLTEKOMC2025-02-26