Somnice, Inc.
TaiwanFDA applicant, unverified
- Devices
- 1
What Somnice, Inc. makes
Somnice, Inc. manufactures the iNAP One Sleep Therapy System, a device designed for non-invasive positive airway pressure (nPAP) therapy to treat obstructive sleep apnea.
The company’s portfolio is regulated under FDA Class II devices and includes submissions via the 510(k) pathway. The system is listed in the FDA’s 510(k) registry. Somnice, Inc. is based in the United States.
Catalogue
The iNAP One Sleep Therapy System Ref K193460
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Somnice, Inc. have in the registry?
The registry currently lists 1 device for Somnice, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Somnice, Inc.'s devices?
Among its 1 most recently registered device, Somnice, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Somnice, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Somnice, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Somnice, Inc. in the registry?
The most recently registered devices listed for Somnice, Inc. include The iNAP One Sleep Therapy System.