Insleep Technologies, LLC
Country not established
- Devices
- 1
What Insleep Technologies, LLC makes
Insleep Technologies, LLC manufactures the Cloud9 System, a medical device designed for non-invasive respiratory support and sleep therapy, including continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) therapies.
The Cloud9 System is classified as a Class II device under FDA regulations and is authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Cloud9 System Ref K150365
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insleep Technologies, LLC have in the registry?
The registry currently lists 1 device for Insleep Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insleep Technologies, LLC's devices?
Among its 1 most recently registered device, Insleep Technologies, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Insleep Technologies, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Insleep Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Insleep Technologies, LLC in the registry?
The most recently registered devices listed for Insleep Technologies, LLC include Cloud9 System.