← Back to catalogue

Tango M2 Blood Pressure Monitor

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K122401

by Suntech Medical, Inc.

Identifiers

510(k) Number
K122401 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tango M2 Blood Pressure Monitor is an automated, non-invasive device designed for continuous blood pressure measurement during stress and exercise testing. It falls under the category of cardiovascular monitoring equipment, specifically tailored for dynamic conditions such as treadmill, ergometer, or pharmacological stress tests. The device employs proprietary algorithms to ensure accuracy despite patient movement or mechanical vibrations, providing reliable readings in clinical settings.

This monitor is supplied as a reusable medical device and is intended for use in cardiology stress labs. It is not sterile and requires proper calibration and maintenance per manufacturer guidelines. The Tango M2 is authorized under FDA 510(k) clearance (K122401) and meets MDR requirements. No specific MRI safety classification is stated, and it is available in a single configuration as specified by the manufacturer.

Frequently asked questions

What types of stress tests is the Tango M2 Blood Pressure Monitor designed to support during use?

The Tango M2 is specifically engineered for dynamic blood pressure monitoring during stress tests involving movement, such as treadmill exercises or ergometer assessments. Its proprietary algorithms account for patient motion and mechanical vibrations, ensuring reliable readings in these conditions. It is not intended for static or resting blood pressure measurements.

Is the Tango M2 Blood Pressure Monitor meant for single-use or repeated use in a clinical setting?

The Tango M2 is classified as a reusable medical device, meaning it is designed for multiple uses in cardiology stress labs. However, it is not sterile, so proper cleaning, calibration, and maintenance per the manufacturer’s guidelines are required between uses to ensure accuracy and safety.

How is the Tango M2 Blood Pressure Monitor authorized for clinical use in the U.S.?

The Tango M2 received FDA clearance through a 510(k) submission (K122401) and is deemed substantially equivalent to a predicate device. The clearance was granted by the Cardiovascular (CV) Advisory Committee under the product code DXN, with a special review classification. This authorization confirms its compliance with U.S. regulatory standards for cardiovascular monitoring equipment.

Can the Tango M2 Blood Pressure Monitor be used in environments with MRI equipment, or are there specific safety concerns?

The manufacturer does not specify an MRI safety classification for the Tango M2, meaning its compatibility with MRI environments is not confirmed. Clinicians should consult the device’s documentation or Suntech Medical for guidance to avoid potential risks, such as interference or damage from magnetic fields, before using it near MRI machines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tango M2 Stress Test Monitor - SunTech Medical, Tango M2 - Blood Pressure for Stress & Exercise Testing SunTech Medical®, SunTech Tango M2 Blood Pressure/Monitor - Davis Medical Electronics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Suntech Medical, Inc.

Sources (2)

  • FDA 510(k) K122401 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026