Omega Results
Country not established
- Devices
- 1
What Omega Results makes
Omega Results develops software for analyzing sleep study data, including the SLEEP STUDY ANALYSIS (SSA) version 96.10, which processes and interprets polysomnography recordings for clinical use.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
Sleep Study Analysis (Ssa) Version 96.10 Ref K963631
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omega Results have in the registry?
The registry currently lists 1 device for Omega Results. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Results's devices?
Among its 1 most recently registered device, Omega Results has devices listed in FDA 510(k) (1 device).
What risk classes do Omega Results's devices fall under?
Among its 1 most recently registered device, the classes recorded for Omega Results's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omega Results in the registry?
The most recently registered devices listed for Omega Results include SLEEP STUDY ANALYSIS (SSA) VERSION 96.10.