Statco Hearing Aid Laboratory
Country not established
- Devices
- 1
What Statco Hearing Aid Laboratory makes
Statco Hearing Aid Laboratory manufactures custom in-the-ear hearing aids designed for individual patient needs. These devices are tailored to fit within the ear canal and are intended to amplify sound for users with varying degrees of hearing loss.
The company’s portfolio is regulated under Class I medical devices in the United States, with products listed via the FDA’s 510(k) pathway. The manufacturer operates from the US, adhering to applicable regulatory standards for hearing aids.
Catalogue
In-The-Ear Hearing Aid Ref K875010
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Statco Hearing Aid Laboratory have in the registry?
The registry currently lists 1 device for Statco Hearing Aid Laboratory. Devices recorded under merged duplicate company entries are counted once.
Which registries list Statco Hearing Aid Laboratory's devices?
Among its 1 most recently registered device, Statco Hearing Aid Laboratory has devices listed in FDA 510(k) (1 device).
What risk classes do Statco Hearing Aid Laboratory's devices fall under?
Among its 1 most recently registered device, the classes recorded for Statco Hearing Aid Laboratory's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Statco Hearing Aid Laboratory in the registry?
The most recently registered devices listed for Statco Hearing Aid Laboratory include IN-THE-EAR HEARING AID.