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FDA 510(k)

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

K-Number: K170565 · 2017-08-01

ApplicantLifewatch Services, Inc.
Decision Date2017-08-01
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is a medical device manufactured by Lifewatch Services, Inc.. It received FDA 510(k) clearance on 2017-08-01 under approval number K170565. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by Lifewatch Services, Inc.. The 510(k) number is K170565.

When was LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L approved by the FDA?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L received FDA 510(k) clearance on 2017-08-01, under approval number K170565.

What company makes LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is manufactured by Lifewatch Services, Inc..

What is the FDA product code for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

The FDA product code for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is QYX.

Related Clinical Trials

NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch RECRUITING NCT07042061 Trial of Mobile External Defibrillator for Out-of-hospital Cardiac Arrest in Singapore. NOT_YET_RECRUITING

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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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