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FDA 510(k)

TelePatch Cardiac Monitor

K-Number: K161916 · 2016-12-21

ApplicantMedicomp, Inc.
Decision Date2016-12-21
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TelePatch Cardiac Monitor is a medical device manufactured by Medicomp, Inc.. It received FDA 510(k) clearance on 2016-12-21 under approval number K161916. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TelePatch Cardiac Monitor?

TelePatch Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Medicomp, Inc.. The 510(k) number is K161916.

When was TelePatch Cardiac Monitor approved by the FDA?

TelePatch Cardiac Monitor received FDA 510(k) clearance on 2016-12-21, under approval number K161916.

What company makes TelePatch Cardiac Monitor?

TelePatch Cardiac Monitor is manufactured by Medicomp, Inc..

What is the FDA product code for TelePatch Cardiac Monitor?

The FDA product code for TelePatch Cardiac Monitor is DRG.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

Other Devices by Medicomp, Inc.

K173170Epicardia Anywhere

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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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