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FDA 510(k)

EKGenius Smart System

K-Number: K232974 · 2023-11-17

ApplicantEkgenius, LLC
Decision Date2023-11-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKGenius Smart System is a medical device manufactured by Ekgenius, LLC. It received FDA 510(k) clearance on 2023-11-17 under approval number K232974. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKGenius Smart System?

EKGenius Smart System is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Ekgenius, LLC. The 510(k) number is K232974.

When was EKGenius Smart System approved by the FDA?

EKGenius Smart System received FDA 510(k) clearance on 2023-11-17, under approval number K232974.

What company makes EKGenius Smart System?

EKGenius Smart System is manufactured by Ekgenius, LLC.

What is the FDA product code for EKGenius Smart System?

The FDA product code for EKGenius Smart System is DPS.

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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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