FDA 510(k)

EP-TRACER System

K-Number: K183266 · 2019-03-01

Decision Date2019-03-01

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EP-TRACER System is a medical device manufactured by Schwarzer Cardiotek GmbH. It received FDA 510(k) clearance on 2019-03-01 under approval number K183266. 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 2019-03-01. It is manufactured by Schwarzer Cardiotek GmbH. The 510(k) number is K183266.

When was EP-TRACER System approved by the FDA?

EP-TRACER System received FDA 510(k) clearance on 2019-03-01, under approval number K183266.

What company makes EP-TRACER System?

EP-TRACER System is manufactured by Schwarzer Cardiotek GmbH.

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.