Handtronix, Inc.
Country not established
- Devices
- 1
What Handtronix, Inc. makes
Handtronix, Inc. manufactures the Otoscreener-I and Otoscreener-I-P, devices designed for hearing screening in infants and young children. These tools are portable and intended for use in clinical or field settings to assess auditory function.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Otoscreener-I And Oto-Screen-I-P Ref K903143
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Handtronix, Inc. have in the registry?
The registry currently lists 1 device for Handtronix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Handtronix, Inc.'s devices?
Among its 1 most recently registered device, Handtronix, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Handtronix, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Handtronix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Handtronix, Inc. in the registry?
The most recently registered devices listed for Handtronix, Inc. include OTOSCREENER-I AND OTO-SCREEN-I-P.