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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 the device name listed in this FDA 510(k) record. The listed applicant is Ekgenius, LLC. It received FDA 510(k) clearance on 2023-11-17 under 510(k) 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. The listed applicant is Ekgenius, LLC. The 510(k) number is K232974.

When did EKGenius Smart System receive FDA 510(k) clearance?

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

Who is the listed applicant for EKGenius Smart System?

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

What is the FDA product code for EKGenius Smart System?

The FDA product code for EKGenius Smart System is DPS.

Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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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