# K121996: BE Plus LTM Amplifier Gwi Amplifier

- Pathway: 510(k) (Special)
- Applicant: Eb Neuro S.P.A.
- Decided: Aug 3, 2012 after 25 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: 3 generations back to K003154 (2001). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053606: BE Plus / Aura-LTM64 Amplifier, Eb Neuro S.P.A. (2006) Summary page 1.

## Most influential descendants
- K133517: Nemus 2 System (2014), 1 descendant of its own
- K242832: NExT Station; NExT Station Advanced (2024), 0 descendants of its own
- K242305: BE Plus PRO, Neurotravel LIGHT (2024), 0 descendants of its own

## Indications for use
The BE Plus LTM / GWi Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

Source page: https://510kreport.com/device/K121996
Methodology: https://510kreport.com/methodology