Ekgenius, LLC
Country not established
- Devices
- 1
What Ekgenius, LLC makes
Ekgenius, LLC manufactures the EKGenius Smart System, a medical device designed for electrocardiogram (ECG) monitoring and analysis, integrating smart technology for real-time cardiac data acquisition and interpretation.
The EKGenius Smart System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
EKGenius Smart System Ref K232974
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ekgenius, LLC have in the registry?
The registry currently lists 1 device for Ekgenius, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ekgenius, LLC's devices?
Among its 1 most recently registered device, Ekgenius, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Ekgenius, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ekgenius, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ekgenius, LLC in the registry?
The most recently registered devices listed for Ekgenius, LLC include EKGenius Smart System.