Neuro-Audio

GUDID 04650075330036

The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-r

NEUROSOFT, OOO

Audiometric/hearing aid tester
Primary Device ID04650075330036
NIH Device Record Keye2a1042d-1fc6-4e93-bc47-6f029fcffdb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro-Audio
Version Model NumberNeuro-Audio
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
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
GS104650075330036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWJStimulator, Auditory, Evoked Response

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

Devices Manufactured by NEUROSOFT, OOO

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04650075335949 - CloudTMS Edge for OCD2024-01-22 No description
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04650075333952 - CloudTMS for OCD2023-12-22 No description.
04650075333969 - CloudTMS for OCD2023-12-22 No description.
04650075332078 - Steadys-Step2023-08-22 System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) da
04650075334003 - aTymp2023-02-10 The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting

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