Oridion, Ltd.
Country not established
- Devices
- 1
What Oridion, Ltd. makes
Oridion, Ltd. manufactures capnography devices, specifically the Polaris 2004, which measures exhaled carbon dioxide (CO₂) levels to monitor respiratory function and ventilation status in clinical settings.
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 operates from the United States.
Catalogue
Polaris 2004 Capnograph Ref K040011
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oridion, Ltd. have in the registry?
The registry currently lists 1 device for Oridion, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oridion, Ltd.'s devices?
Among its 1 most recently registered device, Oridion, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Oridion, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Oridion, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oridion, Ltd. in the registry?
The most recently registered devices listed for Oridion, Ltd. include POLARIS 2004 CAPNOGRAPH.