FDA 510(k)

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

K-Number: K151269 · 2016-01-15

Decision Date2016-01-15

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Technologies , Ltd.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151269. 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 ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Lifewatch Technologies , Ltd.. The 510(k) number is K151269.

When did ECG Mini System Continuous ECG Monitor and Arrhythmia Detector receive FDA 510(k) clearance?

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151269.

Who is the listed applicant for ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

The FDA 510(k) record lists Lifewatch Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

The FDA product code for ECG Mini System Continuous ECG Monitor and Arrhythmia Detector 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.

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Other records listing Lifewatch Technologies , Ltd. as applicant

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Related Devices (Code: DSI)

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 SA K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

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