# K103129: Entropy Easyfit Sensor

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jul 19, 2011 after 270 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K761301 (1977). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082540: GE Entropy Sensor, GE Healthcare (2008) Summary page 1.
- K061907: Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories, GE Healthcare (2008) Summary page 1.

## Indications for use
Entropy EasyFit Sensor is intended to be used for adults and pediatric patients older than 2 years with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable.

Source page: https://510kreport.com/device/K103129
Methodology: https://510kreport.com/methodology