Viridia Component Monitoring System, CMS 24/26, Model Rev. K with EASI-ECG Option

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

Full name

Hp Viridia Component Monitoring System, Hp Viridia Cms 24/26, Model Rev. K with Easi-ECG Option

510(k) Number

K990476 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the HP Viridia CMS 24/26 used for?

  The HP Viridia CMS 24/26 is a physiological patient monitor designed specifically for arrhythmia detection and alarming. It continuously assesses cardiac rhythm disturbances in both adult and pediatric patients, providing real-time monitoring of heart function. This helps clinicians evaluate arrhythmias and related symptoms for accurate clinical assessment, particularly in settings like hospitals and cardiac care units.

• Is the HP Viridia CMS 24/26 a reusable or single-use device?

  The HP Viridia CMS 24/26 is a reusable medical device. As such, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure reliability, safety, and consistent performance over repeated use.

• Can the HP Viridia CMS 24/26 be used in an MRI environment?

  No, the HP Viridia CMS 24/26 is classified as MRI-unsafe. It must only be used in non-magnetic environments to prevent interference or damage to the device, as well as potential harm to patients.

• What does the EASI-ECG option provide in this system?

  The EASI-ECG option integrates ECG capabilities into the HP Viridia CMS 24/26, enabling comprehensive cardiac evaluation. This feature allows for real-time monitoring of heart rhythms, enhancing the system’s ability to detect and assess arrhythmias for clinical decision-making.

• What regulatory clearance does the HP Viridia CMS 24/26 hold?

  The HP Viridia CMS 24/26 holds FDA 510(k) clearance under the classification of Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms). This clearance confirms that the device meets regulatory standards for cardiovascular monitoring and is authorized for use in clinical settings.