FDA.reportPublic FDA data

CNS Envision

Primary DI
B485VIS100
Brand
CNS Envision
Company
MOBERG RESEARCH INC
Model
VIS-100
Device description
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
Published
2020-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software
OMAAmplitude-Integrated Electroencephalograph
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OMAAmplitude-Integrated ElectroencephalographNeurology2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192572000CNS EnvisionMoberg Research, Inc.2019-12-17OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B485VIS100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029957656
Device count
1

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
B485CNSEEG3001Component Neuromonitoring SystemCNS-EEG-3002017-12-21
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
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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