Gn Resound A/S
DenmarkFDA applicant, unverified
- Devices
- 3
What Gn Resound A/S makes
Gn Resound A/S manufactures tinnitus sound generator modules designed to provide auditory stimulation for managing tinnitus symptoms. These devices are intended to mask or distract from ringing in the ears through controlled sound output.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed in the 510(k) registry. The modules are based in the US.
Catalogue
Tinnitus Sound Generator Module Ref K073636
Regimes: 510(k) Registry: 510(k)Tinnitus Sound Generator Module Ref K150171
Regimes: 510(k) Registry: 510(k)Tinnitus Sound Generator Module Ref K110932
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gn Resound A/S have in the registry?
The registry currently lists 3 devices for Gn Resound A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gn Resound A/S's devices?
Among its 3 most recently registered devices, Gn Resound A/S has devices listed in FDA 510(k) (3 devices).
What risk classes do Gn Resound A/S's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gn Resound A/S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gn Resound A/S in the registry?
The most recently registered devices listed for Gn Resound A/S include TINNITUS SOUND GENERATOR MODULE.