# K172312: eego amplifiers

- Pathway: 510(k) (Traditional)
- Applicant: Eemagine Medical Imaging Solutions GmbH
- Decided: Mar 30, 2018 after 241 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 K060374 (2006). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060374: Refa, Physiological Amplifier, Tms International BV (2006) Summary page 4.

## Most influential descendants
- K243746: Delphi Amplifier (2025), 0 descendants of its own
- K201747: 8-CH Electroencephalography Amplifier (2020), 0 descendants of its own

## Indications for use
The eego amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician’s office, etc). The device is not intended for use in life support systems.

Source page: https://510kreport.com/device/K172312
Methodology: https://510kreport.com/methodology