FDA.reportPublic FDA data

Component Monitoring System

Primary DI
B485CNSPTZ3501
Brand
Component Monitoring System
Company
MOBERG RESEARCH INC
Model
CNS-PTZ-350
Device description
Optional camera that can be used to record video of the patient.
Published
2021-04-19
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
B485CNSPTZ3501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical cameraA battery-powered hand-held digital electro-optical device designed to capture video or still image data for a variety of medical applications (e.g., ophthalmoscopic, otoscopic and dermatoscopic) using dedicated interchangeable lenses. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It typically has a user display screen for visualization before image capture, and a docking cradle for battery recharging and connection to a personal computer.

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
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
B485VIS100CNS EnvisionVIS-1002020-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMUD2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMUD2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMUD2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMUD2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.ORT2026-09-04
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.OLT2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06