# K041198: NIC36 Amplifier

- Pathway: 510(k) (Special)
- Applicant: Eb Neuro S.P.A.
- Decided: Jun 1, 2004 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: 1 generation back to K003154 (2001). 1 ancestor in all.
10 later devices descend from it; 1 cites 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.

## Most influential descendants
- K053606: BE Plus / Aura-LTM64 Amplifier (2006), 9 descendants of its own
- 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

## Indications for use
The Nic36 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/K041198
Methodology: https://510kreport.com/methodology