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FDA 510(k)

EnSite X EP System

K-Number: K212061 · 2021-10-22

ApplicantAbbott
Decision Date2021-10-22
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite X EP System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K212061. 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 EnSite X EP System?

EnSite X EP System is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Abbott. The 510(k) number is K212061.

When did EnSite X EP System receive FDA 510(k) clearance?

EnSite X EP System received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212061.

Who is the listed applicant for EnSite X EP System?

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

What is the FDA product code for EnSite X EP System?

The FDA product code for EnSite X EP System is DQK.

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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.

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