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

Standard Polysomnograph With Electroencephalograph (OLV) (5) Full-Montage Standard Electroencephalograph (GWQ) (5) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (5) Transcranial Magnetic Stimulator (OBP) (2) Audiometer (EWO) (1) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1) Device, Nerve Conduction Velocity Measurement (JXE) (1) Electromyograph, Diagnostic (IKN) (1) Stimulator, Auditory, Evoked Response (GWJ) (1)

Premarket Exempt

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Neuro-Audio - 04650075330036 Catalog Number :

Device Description : The Neuro-Audio system is indicated for use in the recording and analysis of hum 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-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.The patient group includes all ages and genders.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Focus - 04650075330074 Catalog Number :

Device Description : 2-channel neurodiagnostic testing system designed to enable reliable recording, 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from thehuman nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : JXE, IKN

Prescription Use : Yes

Device Count : 1

CloudEKG - 04650075330081 Catalog Number :

Device Description : The CloudEKG device is a 12 standard leads battery operated unit intended for The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals.CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Neuron-Spectrum - 04650075330098 Catalog Number :

Device Description : The digital systems Neuron-Spectrum-1 are intended for use as digital neurophys The digital systems Neuron-Spectrum-1 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 8 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 : Yes

Device Count : 1

Neuron-Spectrum - 04650075330104 Catalog Number :

Device Description : The digital systems Neuron-Spectrum-2 are intended for use as digital neurophys The digital systems Neuron-Spectrum-2 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 16 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 : Yes

Device Count : 1

Neuron-Spectrum - 04650075330111 Catalog Number :

Device Description : The digital systems Neuron-Spectrum-3 are intended for use as digital neurophys The digital systems Neuron-Spectrum-3 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 : Yes

Device Count : 1

Neuron-Spectrum - 04650075330128 Catalog Number :

Device Description : The digital systems Neuron-Spectrum-4 are intended for use as digital neurophys The digital systems Neuron-Spectrum-4 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 21 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 : Yes

Device Count : 1

Neuron-Spectrum - 04650075330135 Catalog Number :

Device Description : The digital systems Neuron-Spectrum- 4/P are intended for use as digital neurop The digital systems Neuron-Spectrum- 4/P 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 21EEG channels, up to 4 polygraphic channels ,1 breath channel and 2 direct current channels.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 : Yes

Device Count : 1

Neurosoft - 04650075330197 Catalog Number :

Device Description : The Neurosoft TMS system is indicated for the treatment of Major Depressive Dis The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : OBP

Prescription Use : Yes

Device Count : 1

CloudTMS - 04650075330296 Catalog Number :

Device Description : The CloudTMS system is indicated for the treatment of Major Depressive Disorder The CloudTMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

Device Class : 2

Duns Number: 643212926

Premarket Exempt : No

Product Code : OBP

Prescription Use : Yes

Device Count : 1

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