DEVICE: Neuron-Spectrum (04650075330111)
Device Identifier (DI) Information
Neuron-Spectrum
Neuron-Spectrum-3
In Commercial Distribution
NEUROSOFT, OOO
Neuron-Spectrum-3
In Commercial Distribution
NEUROSOFT, OOO
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11467 | Electroencephalograph |
An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
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FDA Product Code
[?]Product Code | Product Code Name |
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GWQ | Full-Montage Standard Electroencephalograph |
OLV | Standard Polysomnograph With Electroencephalograph |
OLT | Non-Normalizing Quantitative Electroencephalograph Software |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K133995 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
781f2e66-2b03-4398-aeac-65f56db214f6
November 28, 2022
4
September 22, 2016
November 28, 2022
4
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
617 8403253
Jjabre@teleemg.com
Jjabre@teleemg.com