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FDA 510(k)

AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM

K-Number: K091971 · 2009-08-27

ApplicantCorventis, Inc.
Decision Date2009-08-27
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corventis, Inc.. It received FDA 510(k) clearance on 2009-08-27 under 510(k) number K091971. 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 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM?

AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-27. The listed applicant is Corventis, Inc.. The 510(k) number is K091971.

When did AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM receive FDA 510(k) clearance?

AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM received FDA 510(k) clearance on 2009-08-27, under 510(k) number K091971.

Who is the listed applicant for AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM?

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

What is the FDA product code for AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM?

The FDA product code for AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM is DSI.

Related Clinical Trials

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Other records listing Corventis, Inc. as applicant

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.

K113372NUVANT, MOBILC CARDIAC TELEMETRYK113187AVIVO MOBILE PATIENT MANAGEMENTK111917NUVANT, MOBILE CARDIAC TELEMETRYK090696NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEMK083287AVIVO MOBILE PATIENT MANAGEMENT SYSTEM

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

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

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