FDA.reportPublic FDA data

Component Neuromonitoring System

Primary DI
B485CNSEEG3001
Brand
Component Neuromonitoring System
Company
MOBERG RESEARCH INC
Model
CNS-EEG-300
Device description
Optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.
Published
2017-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MUDOximeter, Tissue Saturation
OLTNon-Normalizing Quantitative Electroencephalograph Software
OMAAmplitude-Integrated Electroencephalograph
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MUDOximeter, Tissue SaturationCardiovascular2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OMAAmplitude-Integrated ElectroencephalographNeurology2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080217000COMPONENT NEUROMONITORING SYSTEMMoberg Research, Inc.2008-11-05OMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B485CNSEEG3001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic signal amplifierAn electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them. It could typically be used when using an electroencephalograph (EEG).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029957656
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B485CNS3501Component Neuromonitoring SystemCNS-3502021-02-12
B485CNS3001Component Neuromonitoring SystemCNS-3002017-12-21
B485CNS3101Component Neuromonitoring SystemCNS-3102017-12-21
B485CNS3201Component Neuromonitoring SystemCNS-3202017-12-21
B485CNSEEG2001Component Neuromonitoring SystemCNS-EEG-2002017-12-21
B485CNSEEG2101Component Neuromonitoring SystemCNS-EEG-2102017-12-21
B485CNSEEG2201Component Neuromonitoring SystemCNS-EEG-2202017-12-21
B485CNSEEG3101Component Neuromonitoring SystemCNS-EEG-3102017-12-21
B485CNSEEG3201Component Neuromonitoring SystemCNS-EEG-3202017-12-21
B485CNSINX3001Component Neuromonitoring SystemCNS-INX-3002018-06-06
B485CNSINX3101Component Neuromonitoring SystemCNS-INX-3102018-06-06
B485CNSINX3201Component Neuromonitoring SystemCNS-INX-3202018-06-06
B485VIS100CNS EnvisionVIS-1002020-10-28
B485CNSPTZ3501Component Monitoring SystemCNS-PTZ-3502021-04-19
B485CNSVID3501Component Monitoring SystemCNS-VID-3502020-10-31
B485CNSVID3701Component Monitoring SystemCNS-VID-3702020-10-23
B485CNSVID3001Component Neuromonitoring SystemCNS-VID-3002017-12-21
B485CNSVID3101Component Neuromonitoring SystemCNS-VID-3102017-12-21
B485CNSVID3201Component Neuromonitoring SystemCNS-VID-3202017-12-21
B485CNSPTZ3001Component Neuromonitoring SystemCNS-PTZ-3002019-03-22

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