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FDA 510(k)

Matrix Mini ECG Monitor

K-Number: K152701 · 2016-04-22

ApplicantGlobal Instrumentation, LLC
Decision Date2016-04-22
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Matrix Mini ECG Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Global Instrumentation, LLC. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K152701. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Matrix Mini ECG Monitor?

Matrix Mini ECG Monitor is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Global Instrumentation, LLC. The 510(k) number is K152701.

When did Matrix Mini ECG Monitor receive FDA 510(k) clearance?

Matrix Mini ECG Monitor received FDA 510(k) clearance on 2016-04-22, under 510(k) number K152701.

Who is the listed applicant for Matrix Mini ECG Monitor?

The FDA 510(k) record lists Global Instrumentation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Matrix Mini ECG Monitor?

The FDA product code for Matrix Mini ECG Monitor is DSI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07776964Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)NOT_YET_RECRUITING

Other records listing Global Instrumentation, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252840M12 Telemetry SystemK202456M5 RecorderK162463Matrix Data Management System

Related Devices (Code: DSI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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