Neuro-Biometrix, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Neuro-Biometrix, Inc. makes
Neuro-Biometrix, Inc. manufactures round window catheters, including both electroactive (e-cath) and passive variants, designed for auditory applications.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Round Window E-Cath Ref K973740
Regimes: 510(k) Registry: 510(k)Round Window Cath Ref K965115
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neuro-Biometrix, Inc. have in the registry?
The registry currently lists 2 devices for Neuro-Biometrix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuro-Biometrix, Inc.'s devices?
Among its 2 most recently registered devices, Neuro-Biometrix, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Neuro-Biometrix, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Neuro-Biometrix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neuro-Biometrix, Inc. in the registry?
The most recently registered devices listed for Neuro-Biometrix, Inc. include ROUND WINDOW E-CATH and ROUND WINDOW CATH.