Energex Systems, Inc.
Country not established
- Devices
- 1
What Energex Systems, Inc. makes
Energex Systems, Inc. manufactures the ENERGEX device, a medical system designed for electrophysiological studies and cardiac mapping, enabling detailed visualization of heart activity for diagnostic and research purposes.
The ENERGEX device is classified as a Class II medical device under FDA regulations and is authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Energex Ref K042686
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Energex Systems, Inc. have in the registry?
The registry currently lists 1 device for Energex Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Energex Systems, Inc.'s devices?
Among its 1 most recently registered device, Energex Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Energex Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Energex Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Energex Systems, Inc. in the registry?
The most recently registered devices listed for Energex Systems, Inc. include ENERGEX.