Neuron-Spectrum

GUDID 04650075330111

The digital systems Neuron-Spectrum-3 are intended for use as digital neurophysiological systems intended for recording, processing and display biopo

NEUROSOFT, OOO

Electroencephalograph
Primary Device ID04650075330111
NIH Device Record Key781f2e66-2b03-4398-aeac-65f56db214f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuron-Spectrum
Version Model NumberNeuron-Spectrum-3
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 Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075330111 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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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