# K052756: Datex-Ohmeda S/5 Memory Module, E-Mem

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Nov 1, 2005 after 32 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 K945234 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945234: AS/3 Memory Module, M0MEM, Datex Division Instrumentarium Corp. (1995) Summary page 1.

## Indications for use
The Datex-Ohmeda S/5 TM E-MEM module is indicated for storing patient related physiological data, discrete record keeping events, and menu configurations in removable flash memory cards. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K052756
Methodology: https://510kreport.com/methodology