# K974747: CS/3 Arrhythmia Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Engstrom, Inc.
- Decided: Apr 23, 1998 after 125 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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
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 CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors. The system is intended for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K974747
Methodology: https://510kreport.com/methodology