Bluesom
FranceFDA applicant, unverified
- Devices
- 1
What Bluesom makes
Bluesom manufactures the BluePro, a Class II medical device designed for [specific application not provided in data]. This product is intended for [purpose not detailed in data], adhering to regulatory standards for its category.
The BluePro is regulated under the FDA’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
BluePro Ref K162192
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bluesom have in the registry?
The registry currently lists 1 device for Bluesom. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bluesom's devices?
Among its 1 most recently registered device, Bluesom has devices listed in FDA 510(k) (1 device).
What risk classes do Bluesom's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bluesom's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bluesom in the registry?
The most recently registered devices listed for Bluesom include BluePro.