Sleep Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Sleep Solutions, Inc. makes
Sleep Solutions, Inc. manufactures continuous positive airway pressure (CPAP) machines, including the SILENT NIGHT II and SILENT NIGHT V, designed for treating obstructive sleep apnea by delivering pressurized air to keep airways open during sleep.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The company is based in the United States.
Catalogue
Silent Night Ii Ref K981034
Regimes: 510(k) Registry: 510(k)Silent Night V Ref K000253
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sleep Solutions, Inc. have in the registry?
The registry currently lists 2 devices for Sleep Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sleep Solutions, Inc.'s devices?
Among its 2 most recently registered devices, Sleep Solutions, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sleep Solutions, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sleep Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sleep Solutions, Inc. in the registry?
The most recently registered devices listed for Sleep Solutions, Inc. include SILENT NIGHT II and SILENT NIGHT V.