# K052145: Datex-Ohmeda S/5 Bis Module, E-Bis and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Aug 23, 2005 after 15 days
- Product code: OLW (Index-Generating 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: 4 generations back to K761301 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013389: Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories, Datex-Ohmeda (2002) Summary page 4.

## Indications for use
The Datex-Ohmeda S/5 T BIS Module, E-BIS and accessories are indicated for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) signals of all hospitalized patients. The Bispectral index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K052145
Methodology: https://510kreport.com/methodology