Hypervisor VI Central Monitoring System (Including TMS)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Terminated Z-0798-2013 FDA Class II ·initiated 28 Nov 2012

  Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.

• • Terminated Z-0630-2013 FDA Class II ·initiated 12 May 2011

  There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.

Trade Name

Central Monitoring System

Device Name

Airway Adapter

Model / Reference

60-14100-00/GA3202/GA3212/GA3211/040-001187-00/GA3201/60-14200-00, HYPERVISOR Ⅹ

Primary DI / UDI-DI

06936415972424

Basic UDI-DI

69449040AB010000333D

510(k) Number

K080192 ↗

FDA Product Code

MSX

EMDN Code

Z1203020201 Multi–parameter patient bedside monitors

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 870.2300

EU market of registration

Germany

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

• What clinical environments is the Hypervisor VI Central Monitoring System designed for, and what types of patient data can it monitor in real-time?

  The Hypervisor VI Central Monitoring System is specifically designed for use in hospital or critical care environments where centralized patient oversight is required. It integrates multiple physiological parameters, including vital signs and cardiac data, to provide real-time monitoring across multiple beds or locations. This allows clinicians to track essential metrics like heart rate, blood pressure, and other critical indicators from a single centralized platform.

• Is the Hypervisor VI Central Monitoring System reusable, and if so, what maintenance or storage guidelines should be followed?

  Yes, the Hypervisor VI Central Monitoring System is supplied as a reusable device. To ensure proper functionality and longevity, it must be stored and maintained according to the manufacturer’s guidelines, which likely include regular cleaning, calibration, and environmental controls to prevent damage or contamination.

• What regulatory pathways has the Hypervisor VI Central Monitoring System undergone, and what does this mean for its use in clinical settings?

  The Hypervisor VI Central Monitoring System has received FDA 510(k) clearance under the classification of Class II medical devices, with a decision described as substantially equivalent to a predicate device. It also complies with EU MDR standards. This means the system meets regulatory requirements for safety and effectiveness in clinical settings, ensuring it can be reliably used for centralized patient monitoring in hospitals and critical care units.

• Does the Hypervisor VI Central Monitoring System have any restrictions on its use in specific imaging environments, such as MRI rooms?

  No, the Hypervisor VI Central Monitoring System is not designed with MRI-specific restrictions. It is intended for standard clinical settings, including hospital wards and critical care units, where networked connectivity and centralized monitoring are required. Always follow manufacturer guidelines for proper placement and use in any clinical environment.