# K242832: NExT Station; NExT Station Advanced

- Pathway: 510(k) (Special)
- Applicant: Eb Neuro S.P.A.
- Decided: Dec 12, 2024 after 84 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: 5 generations back to K003154 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133517: Nemus 2 System, Eb Neuro S.P.A. (2014) Summary page 5.
- K142064: Galileo NT, Eb Neuro S.P.A. (2015) Summary page 5.

## Indications for use
The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient’s central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles. The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.

Source page: https://510kreport.com/device/K242832
Methodology: https://510kreport.com/methodology