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(Vcom, Irvs, Rvs) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with

by Data Critical Corporation

510(k) K962473

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)ST Traditional NumberK962473 Date6 Nov 1997DecidedStatusActive

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  • Withdrawn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
MSX
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
ST

Overview

AI-generated summary, 1 Oct 2026

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

The device is a System, Network and Communication, Physiological Monitor designed for continuous cardiac monitoring. It integrates a central monitoring station with V-Link or ambulatory transmitters, along with an arrhythmia detector and alarm system to identify and alert for abnormal heart rhythms. This setup facilitates remote or ambulatory patient monitoring, enabling real-time data transmission for clinical assessment.

The system is supplied as a reusable medical device, intended for use in clinical or ambulatory settings. It operates within Class II regulatory classification under FDA 510(k) clearance (K962473) and is subject to tracking regulations. No specific sterility or MRI safety information is provided in the data, but the device is regulated under the System, Network and Communication, Physiological Monitors category (OpenFDA: device_class=2, regulation_number=870.2300).

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Questions

AI-generated answers, 1 Oct 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 primary purpose of the VCOM Central Monitoring Station?

    The VCOM Central Monitoring Station is designed for continuous cardiac monitoring, integrating a central station with V-Link or ambulatory transmitters to track heart rhythms in real time. It includes an arrhythmia detector and alarm system to identify and alert clinicians to abnormal heart rhythms, enabling remote or ambulatory patient assessment.

  • How is the VCOM Central Monitoring System supplied and intended for use?

    The system is supplied as a reusable medical device, intended for use in clinical or ambulatory settings. It is not single-use and requires proper maintenance and cleaning between patients to ensure reliability and safety.

  • Is the VCOM Central Monitoring System sterile?

    The provided data does not specify whether the device is sterile or requires sterilization. Since it is reusable, it is likely intended for use after cleaning and disinfection rather than as a sterile product.

  • What regulatory classification and clearance does the VCOM Central Monitoring System hold?

    The VCOM Central Monitoring System falls under the System, Network and Communication, Physiological Monitors category and is classified as a Class II medical device. It holds FDA 510(k) clearance (K962473) and is subject to tracking regulations, as it is substantially equivalent to a predicate device.

  • Are there different models or sizes available for the VCOM Central Monitoring System?

    The system includes a central monitoring station paired with V-Link or ambulatory transmitters, but the provided data does not specify distinct models or sizes beyond these core components. The transmitters may vary in design for ambulatory or stationary use, but no explicit sizing details are available.