Orthoapnea S.L.
SpainFDA applicant, unverified FDA FEI 3012359952
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Orthoapnea S.L. makes
Orthoapnea S.L. makes oral appliances for the treatment of sleep apnea and snoring, including the Classic and NOA Sleep Apnea and Snoring Device.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Classic Ref K203477
Regimes: 510(k) Registry: 510(k)NOA Sleep Apnea and Snoring Device Ref K202651
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3012359952
- Address
- C/ Flauta Magica 22, Malaga
Frequently asked questions
How many devices does Orthoapnea S.L. have in the registry?
The registry currently lists 2 devices for Orthoapnea S.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthoapnea S.L.'s devices?
Among its 2 most recently registered devices, Orthoapnea S.L. has devices listed in FDA 510(k) (2 devices).
What risk classes do Orthoapnea S.L.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orthoapnea S.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthoapnea S.L. in the registry?
The most recently registered devices listed for Orthoapnea S.L. include Classic and NOA Sleep Apnea and Snoring Device.