Bien-Air Sa Switzerland
SwitzerlandFDA applicant, unverified
- Devices
- 1
What Bien-Air Sa Switzerland makes
Bien-Air SA manufactures the OPTIMA MX, a medical device designed for respiratory therapy, specifically for oxygen concentration and delivery in clinical settings.
The OPTIMA MX is classified as a Class I device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in Switzerland but operates in the US market.
Catalogue
Optima Mx Ref K042759
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bien-Air SA Switzerland have in the registry?
The registry currently lists 1 device for Bien-Air SA Switzerland. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bien-Air SA Switzerland's devices?
Among its 1 most recently registered device, Bien-Air SA Switzerland has devices listed in FDA 510(k) (1 device).
What risk classes do Bien-Air SA Switzerland's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bien-Air SA Switzerland's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bien-Air SA Switzerland in the registry?
The most recently registered devices listed for Bien-Air SA Switzerland include OPTIMA MX.