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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 a medical device manufactured by Cath Vision Aps. It received FDA 510(k) clearance on 2023-08-04 under approval 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. It is manufactured by Cath Vision Aps. The 510(k) number is K223787.

When was ECGenius System approved by the FDA?

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

What company makes ECGenius System?

ECGenius System is manufactured by Cath Vision Aps.

What is the FDA product code for ECGenius System?

The FDA product code for ECGenius System is DQK.

Other Devices by Cath Vision Aps

K220306ECGenius System

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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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