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FDA 510(k)

CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM

K-Number: K002604 · 2002-02-07

ApplicantInvivo Research, Inc.
Decision Date2002-02-07
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research, Inc.. It received FDA 510(k) clearance on 2002-02-07 under 510(k) number K002604. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM?

CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-07. The listed applicant is Invivo Research, Inc.. The 510(k) number is K002604.

When did CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 2002-02-07, under 510(k) number K002604.

Who is the listed applicant for CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM?

The FDA 510(k) record lists Invivo Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM?

The FDA product code for CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM is DSI.

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Other records listing Invivo Research, Inc. as applicant

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Related Devices (Code: DSI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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