Data / Medical devices / United States / Neurosigma, Inc.
Neurosigma, Inc.: FDA-registered device maker in Los Angeles, CA, United States, 2 510(k) clearances
Neurosigma, Inc. is registered with the FDA (registration 3011845821) in Los Angeles, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011845821
- Address
- 10960 Wilshire Blvd. Suite 1910, Los Angeles, CA, United States, 90024
- Owner or operator
- NeuroSigma, Inc. (10060896)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 9, 2019
- Registered through
- 2026
- Brand names listed
- Generation 2 Monarch external Trigeminal Nerve Stimulation (eTNS) System®, Monarch NS-2 Electric Patch, Monarch eTNS System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transcutaneous Nerve Stimulator For Adhd | QGL | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2024 | K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | QGL | Substantially Equivalent | Neurosigma, Inc. | accessdata.fda.gov |
| April 19, 2019 | DEN180041 | Monarch eTNS System | QGL | Unknown | Neurosigma, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.