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Centurion 2000 Central Station Arrhythmia Patient Monitoring System

by Invivo Research, Inc.

510(k) K002604

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002604 Date7 Feb 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.