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FDA 510(k)

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

K-Number: K151269 · 2016-01-15

ApplicantLifewatch Technologies , Ltd.
Decision Date2016-01-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

When was ECG Mini System Continuous ECG Monitor and Arrhythmia Detector approved by the FDA?

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

What company makes ECG Mini System Continuous ECG Monitor and Arrhythmia Detector?

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is manufactured by Lifewatch Technologies , Ltd..

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.

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Related PubMed Literature

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Official Source

View on FDA Database →

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