Omega Point Systems, LLC
Country not established
- Devices
- 1
What Omega Point Systems, LLC makes
Omega Point Systems, LLC manufactures the BreathKey Model G10 and BreathKey Model G30X, which are portable devices designed for monitoring respiratory patterns and detecting sleep-related breathing disorders.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Breathkey Model G10/Breathkey Model G30X Ref K052804
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omega Point Systems, LLC have in the registry?
The registry currently lists 1 device for Omega Point Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Point Systems, LLC's devices?
Among its 1 most recently registered device, Omega Point Systems, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Omega Point Systems, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Omega Point Systems, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Omega Point Systems, LLC in the registry?
The most recently registered devices listed for Omega Point Systems, LLC include BREATHKEY MODEL G10/BREATHKEY MODEL G30X.