# K980045: Centurion Central Station Arrhythmia Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Nov 16, 1998 after 314 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
Longest line of descent: 2 generations back to K903702 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962473: (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with, Data Critical Corporation (1997) Summary page 1.
- K925411: Model 2041-PC/ST Cardiac Telemetry Monitor, Accucore, Inc. (1993) Summary page 1.
- K913576: Datascope Model Visa Central Monitor, Accucore, Inc. (1992). Our OCR of the scanned summary read K913676, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Datascope VISA Central Station with Arrhythmia Monitor”.
- K933404: Critikon Central Statin Monitor, Critikon Company, LLC (1994) Summary page 1.

## Indications for use
The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients’ cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications..

Source page: https://510kreport.com/device/K980045
Methodology: https://510kreport.com/methodology