Centurion 2000 Central Station Arrhythmia Patient Monitoring System
510(k) K002604
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002604 | Date7 Feb 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Centurion 2000 Central Station Arrhythmia Patient Monitoring System is a device intended for general hospital or clinical use by medical professionals. It provides the centralized display, storage and recording of patient vital sign and waveform data that is being monitored.
The system is supplied as a Class 2 device with FDA 510(k) clearance K002604, determined to be substantially equivalent. It is manufactured by Invivo Research, Inc. and is designed for use in cardiovascular settings.
Other devices from Invivo Research, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the Centurion 2000 Central Station Arrhythmia Patient Monitoring System used for?
The Centurion 2000 is designed for general hospital or clinical use by medical professionals. It provides centralized display, storage and recording of patient vital sign and waveform data that is being monitored in cardiovascular settings.
How is the Centurion 2000 system supplied and what is its regulatory status?
The system is supplied as a Class 2 device with FDA 510(k) clearance K002604, determined to be substantially equivalent. It is manufactured by Invivo Research, Inc. and is designed for use in cardiovascular settings.
What are the key features of the Centurion 2000 monitoring system?
The Centurion 2000 provides centralized display, storage and recording of patient vital sign and waveform data. It is intended for general hospital or clinical use by medical professionals and is specifically designed for cardiovascular settings.
Who manufactures the Centurion 2000 Central Station Arrhythmia Patient Monitoring System?
The Centurion 2000 is manufactured by Invivo Research, Inc., located in Orlando, Florida. The company is responsible for the production and distribution of this monitoring system for clinical use.