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M12 Telemetry System

by Global Instrumentation LLC

510(k) K252840

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252840 Date29 May 2026ClearedStatusActive

Official records

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  • Withdrawn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
MHX
FDA applicant
Global Instrumentation, LLC
Device class
Class II
Regulation
21 CFR Part 870.1025
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

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 M12 Telemetry System is a physiological patient monitor designed for arrhythmia detection and alarm capabilities. Classified as a Class II medical device, it is intended for continuous or intermittent monitoring of cardiac electrical activity, enabling real-time assessment of heart rhythm abnormalities. Its primary function aligns with the OpenFDA classification of a monitor for physiological patient use, specifically tailored for detecting arrhythmias and triggering alarms when irregularities are identified.

This system is supplied as a reusable medical device, intended for use in clinical settings such as hospitals, research facilities, and cardiac care units. It operates within standard MRI safety guidelines for non-MRI environments and is not intended for use inside MRI scanners. The device is regulated under FDA 510(k) clearance (K252840) and falls under the regulatory category 870.1025, with a product code of MHX. It requires proper storage and maintenance as outlined in manufacturer guidelines to ensure accurate and reliable performance.

From the manufacturer

WHAT WE DO Global Instrumentation, LLC ("GI") provides customized cardiac diagnostic and monitoring solutions to clinical researchers, cardiac monitoring service providers, and medical technology developers seeking precision ECG data collection and flexible data management tools.

Source: globalinstrumentation.com

Proven across years of research use, the Global Instrumentation family of ECG recorders provide the highest quality of ECG data. All devices seamlessly integrate with the M12A Enterprise Software Platform and offer BlueTooth™ connectivity for fast and efficient recorder set-up an initialization.

Source: globalinstrumentation.com

Similar devices

Other devices filed under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

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