Neuron-Spectrum

GUDID 04650075333211

The digital systems CloudEEG are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 19 EEG channels, 1 polygraphic channel and 1 breath channel. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.

NEUROSOFT, OOO

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Primary Device ID04650075333211
NIH Device Record Key6b3d49e2-8ad2-4f28-a30d-33f77c3fc66b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuron-Spectrum
Version Model NumberCloudEEG
Company DUNS643212926
Company NameNEUROSOFT, OOO
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075333211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-30
Device Publish Date2021-07-22

On-Brand Devices [Neuron-Spectrum]

04650075330135The digital systems Neuron-Spectrum- 4/P are intended for use as digital neurophysiological sys
04650075330128The digital systems Neuron-Spectrum-4 are intended for use as digital neurophysiological system
04650075330111The digital systems Neuron-Spectrum-3 are intended for use as digital neurophysiological system
04650075330104The digital systems Neuron-Spectrum-2 are intended for use as digital neurophysiological system
04650075330098The digital systems Neuron-Spectrum-1 are intended for use as digital neurophysiological system
04650075333211The digital systems CloudEEG are intended for use as digital neurophysiological systems intende

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