Concha Labs
Country not established
- Devices
- 1
What Concha Labs makes
Concha Labs manufactures the Concha Sol Hearing Aids (CL-1001), a device designed to amplify sound for individuals with hearing loss.
The Concha Sol Hearing Aids are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Concha Sol Hearing Aids (CL-1001) Ref K233747
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Concha Labs have in the registry?
The registry currently lists 1 device for Concha Labs. Devices recorded under merged duplicate company entries are counted once.
Which registries list Concha Labs's devices?
Among its 1 most recently registered device, Concha Labs has devices listed in FDA 510(k) (1 device).
What risk classes do Concha Labs's devices fall under?
Among its 1 most recently registered device, the classes recorded for Concha Labs's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Concha Labs in the registry?
The most recently registered devices listed for Concha Labs include Concha Sol Hearing Aids (CL-1001).