University of Otago
Country not established
- Devices
- 1
What University of Otago makes
The University of Otago manufactures a tongue stabilizer device, designed to assist in speech therapy or oral rehabilitation by positioning the tongue for improved function or stability.
This device is classified as Class II under FDA regulations and is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Tongue Stabilizer Device Ref K993381
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does University of Otago have in the registry?
The registry currently lists 1 device for University of Otago. Devices recorded under merged duplicate company entries are counted once.
Which registries list University of Otago's devices?
Among its 1 most recently registered device, University of Otago has devices listed in FDA 510(k) (1 device).
What risk classes do University of Otago's devices fall under?
Among its 1 most recently registered device, the classes recorded for University of Otago's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from University of Otago in the registry?
The most recently registered devices listed for University of Otago include TONGUE STABILIZER DEVICE.