Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System

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

510(k) Number

K091971 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System

  Class II

  FDA 510(k) K090696 Active Cleared 19 Jun 2009

• Nuvant Mct System

  Class II

  FDA 510(k) K133701 Active Cleared 6 Feb 2014

• Nuvant, Mobile Cardiac Telemetry

  Class II

  FDA 510(k) K111917 Active Cleared 24 Aug 2011

• Avivo Mobile Patient Management

  Class II

  FDA 510(k) K113187 Active Cleared 4 Jan 2012

• Nuvant, Mobilc Cardiac Telemetry

  Class II

  FDA 510(k) K113372 Active Cleared 7 Mar 2012

• Avivo Mobile Patient Management System

  Class II

  FDA 510(k) K083287 Active Cleared 3 Feb 2009

• What is the primary purpose of the Nuvant Mobile Cardiac Telemetry (MCT) System?

  The Nuvant Mobile Cardiac Telemetry (MCT) System is designed as a Detector and Alarm, Arrhythmia device to continuously monitor and record physiological data for the detection of non-lethal cardiac arrhythmias. It is specifically intended for use in clinical and ambulatory settings, where real-time patient assessment is required in mobile environments. The system transmits stored data periodically for remote review, enabling clinicians to track cardiac activity without continuous on-site supervision.

• How is the Nuvant Mobile Cardiac Telemetry (MCT) System supplied, and is it single-use or reusable?

  The Nuvant Mobile Cardiac Telemetry (MCT) System is supplied as a mobile solution for ambulatory or clinical use. Based on the available regulatory data, there are no explicit sterility or single-use specifications mentioned, meaning it is likely intended for reusable applications in controlled environments. However, proper cleaning, disinfection, and maintenance protocols would be required to ensure patient safety and device functionality.

• Does the Nuvant Mobile Cardiac Telemetry (MCT) System come in different sizes or models?

  The device data includes multiple FEI (Facility Establishment Information) numbers, which may correspond to different models or configurations of the Nuvant Mobile Cardiac Telemetry (MCT) System. While the exact specifications for each model are not detailed in the provided data, these identifiers suggest the system may be available in various versions or configurations to accommodate different clinical or ambulatory needs. For precise sizing or model details, refer to the manufacturer’s documentation or contact Corventis, Inc.

• How should the Nuvant Mobile Cardiac Telemetry (MCT) System be stored?

  The regulatory data does not specify storage conditions for the Nuvant Mobile Cardiac Telemetry (MCT) System. However, as a mobile medical device, it should be stored in a clean, dry, and temperature-controlled environment to prevent damage from humidity, extreme temperatures, or physical stress. If the device is reusable, it should also be stored in a manner that ensures proper hygiene and protection before and after use, following manufacturer guidelines for maintenance and cleaning.

• What regulatory pathway does the Nuvant Mobile Cardiac Telemetry (MCT) System follow?

  The Nuvant Mobile Cardiac Telemetry (MCT) System holds FDA 510(k) clearance (K091971) under a Special Substantial Equivalence (SESE) determination, classified as a Class II device under 21 CFR 870.1025. This classification indicates it is intended for continuous cardiac monitoring and falls under the Cardiovascular advisory committee review. The system is not explicitly marked as sterile or single-use, meaning its regulatory compliance is tied to its intended use in mobile or ambulatory cardiac telemetry applications.