Accutone, Inc.
Country not established
- Devices
- 1
What Accutone, Inc. makes
Accutone, Inc. manufactures auditory trainers, which are devices designed to improve hearing and auditory processing through targeted exercises and sound stimulation.
The company’s auditory trainers are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The devices are based in the United States.
Catalogue
Auditory Trainer Ref K771671
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accutone, Inc. have in the registry?
The registry currently lists 1 device for Accutone, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accutone, Inc.'s devices?
Among its 1 most recently registered device, Accutone, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Accutone, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Accutone, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accutone, Inc. in the registry?
The most recently registered devices listed for Accutone, Inc. include AUDITORY TRAINER.