Bionique
Country not established
- Devices
- 1
What Bionique makes
Bionique manufactures multicomponent systems designed for high-channel neural signal recording, supporting applications in neurophysiology and research environments. These systems capture and process electrical signals from neural tissues, enabling detailed data acquisition for experimental and clinical studies.
The company’s devices are classified under FDA’s Class II regulatory category and are authorised via the 510(k) pathway. These products are registered with the FDA’s premarket notification process. The manufacturer is based in the United States.
Catalogue
Multichannel Recording System Ref K912427
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionique have in the registry?
The registry currently lists 1 device for Bionique. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionique's devices?
Among its 1 most recently registered device, Bionique has devices listed in FDA 510(k) (1 device).
What risk classes do Bionique's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bionique's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionique in the registry?
The most recently registered devices listed for Bionique include MULTICHANNEL RECORDING SYSTEM.