# K051883: Datex-Ohmeda S/5 Eeg Module, E-Eeg and Datex-Ohmeda S/5 Eeg Headbox, N-Eeg and Accessories.

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Aug 5, 2005 after 24 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: 1 generation back to K000892 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000892: Datex-Ohmeda Eeg Module, M-Eeg and Datex-Ohmeda Eeg Headbox, N-Eeg and Accessories, Datex-Ohmeda, Inc. (2000) Summary page 2.

## Most influential descendants
- K191322: E-Eegx, N-Eegx (2020), 0 descendants of its own

## Indications for use
The Datex-Ohmeda S/5™ EEG module, E-EEG and the Datex-Ohmeda S/5™ EEG headbox, N-EEG and accessories are indicated for monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG) and auditory evoked potentials (AEP) of all hospital patients. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K051883
Methodology: https://510kreport.com/methodology