# K191322: E-Eegx, N-Eegx

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Jan 22, 2020 after 252 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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: 2 generations back to K000892 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051883: Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and Accessories., GE Healthcare (2005) Summary page 5.

## Indications for use
The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K191322
Methodology: https://510kreport.com/methodology