Optex Biomedical
Country not established
- Devices
- 1
What Optex Biomedical makes
Optex Biomedical manufactures the OPTEX Blood Gas Monitoring System, a device designed for analyzing arterial and venous blood gases, electrolytes, and metabolites to support clinical decision-making in critical care settings.
The OPTEX Blood Gas Monitoring System is classified as a Class II medical device in the US and is listed under FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Optex Blood Gas Monitoring System Ref K896311
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optex Biomedical have in the registry?
The registry currently lists 1 device for Optex Biomedical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optex Biomedical's devices?
Among its 1 most recently registered device, Optex Biomedical has devices listed in FDA 510(k) (1 device).
What risk classes do Optex Biomedical's devices fall under?
Among its 1 most recently registered device, the classes recorded for Optex Biomedical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optex Biomedical in the registry?
The most recently registered devices listed for Optex Biomedical include OPTEX BLOOD GAS MONITORING SYSTEM.