FDA 510(k)

EP-TRACER System

K-Number: K161245 · 2016-08-05

Decision Date2016-08-05

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EP-TRACER System is a medical device manufactured by Cardio Tek, BV. It received FDA 510(k) clearance on 2016-08-05 under approval number K161245. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EP-TRACER System?

EP-TRACER System is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Cardio Tek, BV. The 510(k) number is K161245.

When was EP-TRACER System approved by the FDA?

EP-TRACER System received FDA 510(k) clearance on 2016-08-05, under approval number K161245.

What company makes EP-TRACER System?

EP-TRACER System is manufactured by Cardio Tek, BV.

What is the FDA product code for EP-TRACER System?

The FDA product code for EP-TRACER System is DQK.

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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.