# K053606: BE Plus / Aura-LTM64 Amplifier

- Pathway: 510(k) (Special)
- Applicant: Eb Neuro S.P.A.
- Decided: Jan 24, 2006 after 28 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: 2 generations back to K003154 (2001). 2 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003154: Mizar, Basis BE, Sandman Digital, Eb Neuro S.P.A. (2001) Summary page 1.
- K041198: NIC36 Amplifier, Eb Neuro S.P.A. (2004) Summary page 1.

## Most influential descendants
- K121996: BE Plus LTM Amplifier Gwi Amplifier (2012), 3 descendants of its own
- K101691: Lifelines Photic Stimulator (2010), 3 descendants of its own
- K133517: Nemus 2 System (2014), 1 descendant of its own
- K251366: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (2025), 0 descendants of its own
- K242832: NExT Station; NExT Station Advanced (2024), 0 descendants of its own

## Indications for use
The BE Plus / AURA-LTM64 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/K053606
Methodology: https://510kreport.com/methodology