Acousticon GmbH
Country not established
- Devices
- 1
What Acousticon GmbH makes
Acousticon GmbH manufactures the ACAM 5 Audiometer System, a diagnostic device used for assessing hearing function through pure-tone audiometry and speech testing in clinical settings.
The ACAM 5 Audiometer System is classified as a Class II medical device and is listed under the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Acam 5 Audiometer System Ref K103298
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Acousticon GmbH have in the registry?
The registry currently lists 1 device for Acousticon GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acousticon GmbH's devices?
Among its 1 most recently registered device, Acousticon GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Acousticon GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Acousticon GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acousticon GmbH in the registry?
The most recently registered devices listed for Acousticon GmbH include ACAM 5 AUDIOMETER SYSTEM.