NEUROSOFT, OOO

Address:5 Voronin Street,Ivanovo Ivanovskaya Oblast',RU

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Electrical, Evoked Response (GWF) (2) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (2) Full-Montage Standard Electroencephalograph (GWQ) (1) Stimulator, Auditory, Evoked Response (GWJ) (1) Stimulator, Photic, Evoked Response (GWE) (1) Standard Polysomnograph With Electroencephalograph (OLV) (1) Neurosurgical Nerve Locator (PDQ) (1)

Premarket Exempt

Clear

Neuro-IOM - 04650075330371 Catalog Number :

Device Description : Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for in 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.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : GWF, GWE, GWJ, OLT, PDQ

Prescription Use : Yes

Device Count : 1

MEGA-TMS - 04650075333174 Catalog Number :

Device Description : The device is intended for magnetic stimulation of peripheral nerves. The obtain The device is intended for magnetic stimulation of peripheral nerves. The obtained responses of stimulated structures can be recorded with EMG system for further diagnostic evaluation.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : GWF

Prescription Use : No

Device Count : 1

Neuron-Spectrum - 04650075333211 Catalog Number :

Device Description : The digital systems CloudEEG are intended for use as digital neurophysiological 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.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : GWQ, OLV, OLT

Prescription Use : No

Device Count : 1

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