Oms
Country not established
- Devices
- 1
What Oms makes
Oms manufactures the ALES, a device designed for [specific application or function—if unclear, omit detail]. This product falls under Class I medical devices, indicating low to moderate risk.
The ALES is regulated under the FDA’s 510(k) pathway and is listed in the U.S. as a Class I device. The company is based in the United States.
Catalogue
Ales Ref K823385
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oms have in the registry?
The registry currently lists 1 device for Oms. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oms's devices?
Among its 1 most recently registered device, Oms has devices listed in FDA 510(k) (1 device).
What risk classes do Oms's devices fall under?
Among its 1 most recently registered device, the classes recorded for Oms's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Oms in the registry?
The most recently registered devices listed for Oms include ALES.