Neurosigma, Inc.
United StatesFDA applicant, unverified FDA FEI 3011845821
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Regimes: 510(k) Registry: 510(k)
Monarch eTNS System Ref DEN180041
Regimes: De Novo Registry: De Novo
Company details
- FDA FEI number
- 3011845821
- Address
- 10960 Wilshire Blvd., Los Angeles, CA, 90024
Frequently asked questions
How many devices does Neurosigma, Inc. have in the registry?
The registry currently lists 2 devices for Neurosigma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neurosigma, Inc.'s devices?
Among its 2 most recently registered devices, Neurosigma, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Neurosigma, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Neurosigma, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neurosigma, Inc. in the registry?
The most recently registered devices listed for Neurosigma, Inc. include Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® and Monarch eTNS System.