Atrix
Country not established
- Devices
- 2
What Atrix makes
Atrix manufactures Class II medical devices, including the CARDISUNY 501 A, a cardiac monitoring system designed for continuous electrocardiogram (ECG) recording, and the MODEL 503FB, a portable defibrillator for emergency cardiac resuscitation. These devices are intended for use in clinical and pre-hospital settings to diagnose arrhythmias and deliver life-saving electrical therapy.
The company’s devices are regulated under the FDA’s 510(k) pathway as Class II medical devices, indicating they pose moderate risk and require pre-market notification. They are listed in the FDA’s 510(k) database, and the company is headquartered in the United States.
Catalogue
Cardisuny 501 A Ref K852829
510(k) 510(k)Model 503FB Ref K842759
510(k) 510(k)
Frequently asked questions
How many devices does Atrix have in the registry?
The registry currently lists 2 devices for Atrix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Atrix's devices?
Among its 2 most recently registered devices, Atrix has devices listed in FDA 510(k) (2 devices).
What risk classes do Atrix's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Atrix's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Atrix in the registry?
The most recently registered devices listed for Atrix include CARDISUNY 501 A and MODEL 503FB.