Neuron-Spectrum - The digital systems Neuron-Spectrum-2 are - NEUROSOFT, OOO

Duns Number:643212926

Device Description: The digital systems Neuron-Spectrum-2 are intended for use as digital neurophysiological 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.

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More Product Details

Catalog Number

-

Brand Name

Neuron-Spectrum

Version/Model Number

Neuron-Spectrum-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133995

Product Code Details

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Device Record Status

Public Device Record Key

013fa076-0e75-4331-b26a-0fbbec0a9a11

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUROSOFT, OOO" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13