American Sleep Association
Country not established
- Devices
- 1
What American Sleep Association makes
The American Sleep Association manufactures oral appliances designed to treat obstructive sleep apnea by repositioning the jaw or tongue to maintain an open airway during sleep.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Asa Oral Appliances Ref K130504
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Sleep Association have in the registry?
The registry currently lists 1 device for American Sleep Association. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Sleep Association's devices?
Among its 1 most recently registered device, American Sleep Association has devices listed in FDA 510(k) (1 device).
What risk classes do American Sleep Association's devices fall under?
Among its 1 most recently registered device, the classes recorded for American Sleep Association's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Sleep Association in the registry?
The most recently registered devices listed for American Sleep Association include ASA ORAL APPLIANCES.