# K974101: Datex-Engstrom Network

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Engstrom, Inc.
- Decided: Feb 6, 1998 after 99 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices. The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS). The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.

Source page: https://510kreport.com/device/K974101
Methodology: https://510kreport.com/methodology