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NeMus 2 System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K133517

by EB Neuro S.p.A.

Identifiers

510(k) Number
K133517 FDA 510(k)
FDA Product Code
GWL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1835 FDA 510(k)
Regulation Number
882.1835 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NeMus 2 System is a physiological signal amplifier designed for neurophysiological monitoring and diagnostic purposes, including electroencephalography (EEG) and somatosensory evoked potentials (SEP). It is classified as a Class II medical device under FDA regulations, intended for recording and analyzing neural signals in clinical settings.

This system is supplied as a reusable, multi-channel amplifier with expandable features, intended for use in intensive care units (ICU) and neurophysiological laboratories. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with specific compliance to regulation number 882.1835. The device supports various monitoring applications, including EEG and SEP with alternating bilateral stimulation, and is intended for use by trained personnel in clinical environments.

Frequently asked questions

What clinical applications is the NEMUS 2 System primarily designed for, and where would it typically be used?

The NEMUS 2 System is designed for neurophysiological monitoring and diagnostic purposes, specifically for recording and analyzing neural signals like electroencephalography (EEG) and somatosensory evoked potentials (SEP), including those with alternating bilateral stimulation. It is intended for use in clinical settings such as intensive care units (ICU) and neurophysiological laboratories by trained personnel.

Is the NEMUS 2 System a single-use or reusable device, and how does this affect its maintenance?

The NEMUS 2 System is a reusable, multi-channel amplifier. Since it is not single-use, proper cleaning, calibration, and maintenance procedures must be followed to ensure consistent performance and compliance with clinical standards. The reusable nature allows for long-term use in clinical environments like ICUs and neurophysiology labs.

What regulatory pathways has the NEMUS 2 System undergone, and how does this impact its use in the U.S.?

The NEMUS 2 System has undergone FDA 510(k) clearance and is classified as a Class II medical device under FDA regulations. This means it has been reviewed and deemed substantially equivalent to a predicate device, allowing it to be legally marketed and used in the U.S. for its intended neurophysiological monitoring applications. The system also complies with the EU Medical Device Regulation (MDR).

Does the NEMUS 2 System come with any specific accessories or configurations, and how does it expand its functionality?

The NEMUS 2 System is a multi-channel amplifier with expandable features, though the exact accessories or configurations are not detailed in the provided data. Its design supports various monitoring applications, including EEG and SEP, and is intended for flexibility in clinical settings. The expandability likely allows for additional channels or modules to be added as needed for specific diagnostic or monitoring tasks.

How does the NEMUS 2 System’s regulatory classification (Class II) influence its use in clinical environments?

The NEMUS 2 System’s classification as a Class II medical device under FDA regulations means it is subject to stricter controls than Class I devices but does not require the same level of scrutiny as Class III. This classification ensures that the device undergoes thorough review for safety and effectiveness, particularly in neurophysiological monitoring where accuracy is critical. Clinicians can rely on its regulatory status as an indicator of its compliance with FDA standards for use in ICUs and neurophysiology labs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NeMus 2 - EBNeuro, NeMus 2 - EBNeuro, Mediproud Company - NeMus2

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
EB Neuro S.p.A.

Sources (2)

  • FDA 510(k) K133517 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026