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FDA 510(k)

ECGenius System

K-Number: K223787 · 2023-08-04

ApplicantCath Vision Aps
Decision Date2023-08-04
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECGenius System is the device name listed in this FDA 510(k) record. The listed applicant is Cath Vision Aps. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K223787. 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 ECGenius System?

ECGenius System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Cath Vision Aps. The 510(k) number is K223787.

When did ECGenius System receive FDA 510(k) clearance?

ECGenius System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K223787.

Who is the listed applicant for ECGenius System?

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

What is the FDA product code for ECGenius System?

The FDA product code for ECGenius System is DQK.

Other records listing Cath Vision Aps as applicant

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.

K220306ECGenius System

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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