Neuro-IOM

GUDID 04650075330371

Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist.

NEUROSOFT, OOO

Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system
Primary Device ID04650075330371
NIH Device Record Keya256d837-17f7-4ce4-abcc-dbd397246e01
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro-IOM
Version Model NumberNeuro-IOM
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075330371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFStimulator, Electrical, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-18
Device Publish Date2021-06-10

Devices Manufactured by NEUROSOFT, OOO

04650075335895 - CloudTMS Edge for OCD2024-01-22 The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-C
04650075335932 - CoudTMS Edge for OCD2024-01-22 No description
04650075335949 - CloudTMS Edge for OCD2024-01-22 No description
04650075333792 - CloudTMS for OCD2023-12-22 The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compu
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.