# K133517: Nemus 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Eb Neuro S.P.A.
- Decided: Feb 26, 2014 after 103 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003154 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073415: Nemus System; Nemus PC Peripheral, Eb Neuro S.P.A. (2008) Summary page 1.
- K121996: BE Plus LTM Amplifier Gwi Amplifier, Eb Neuro S.P.A. (2012) Summary page 4.

## Most influential descendants
- K242832: NExT Station; NExT Station Advanced (2024), 0 descendants of its own

## Indications for use
The Nemus 2 System is intended to acquire the bioclectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nernus 2 System consists of a physiological signal amplifier, an evoked response auditory stimulator, an evoked response electrical stimulator, and an evoked response photic stimulator. The user needs to assure compatibility or the Nemus 2 System to the other components of the user's own System.

Source page: https://510kreport.com/device/K133517
Methodology: https://510kreport.com/methodology