Ototech Intl., Inc.
Country not established
- Devices
- 1
What Ototech Intl., Inc. makes
Ototech Intl., Inc. manufactures behind-the-ear hearing instruments, including the Model ALPHA, designed for auditory amplification.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Model Alpha Behind-The-Ear Hearing Instrument Ref K962228
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ototech Intl., Inc. have in the registry?
The registry currently lists 1 device for Ototech Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ototech Intl., Inc.'s devices?
Among its 1 most recently registered device, Ototech Intl., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Ototech Intl., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ototech Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ototech Intl., Inc. in the registry?
The most recently registered devices listed for Ototech Intl., Inc. include MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT.