O'Neill
Country not established
- Devices
- 1
What O'Neill makes
O'Neill manufactures the Supine Stress System, a device designed for assessing cardiovascular response under controlled stress conditions in a supine position.
The Supine Stress System is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Supine Stress System Ref K810238
510(k) 510(k)
Frequently asked questions
How many devices does O'Neill have in the registry?
The registry currently lists 1 device for O'Neill. Devices recorded under merged duplicate company entries are counted once.
Which registries list O'Neill's devices?
Among its 1 most recently registered device, O'Neill has devices listed in FDA 510(k) (1 device).
What risk classes do O'Neill's devices fall under?
Among its 1 most recently registered device, the classes recorded for O'Neill's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from O'Neill in the registry?
The most recently registered devices listed for O'Neill include SUPINE STRESS SYSTEM.