Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EP-TRACER System

K-Number: K183266 · 2019-03-01

ApplicantSchwarzer Cardiotek GmbH
Decision Date2019-03-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP-TRACER System is the device name listed in this FDA 510(k) record. The listed applicant is Schwarzer Cardiotek GmbH. It received FDA 510(k) clearance on 2019-03-01 under 510(k) 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. The listed applicant is Schwarzer Cardiotek GmbH. The 510(k) number is K183266.

When did EP-TRACER System receive FDA 510(k) clearance?

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

Who is the listed applicant for EP-TRACER System?

The FDA 510(k) record lists Schwarzer Cardiotek GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.

↑