NEUROSIGMA, INC.

FDA Device Registration & Listing · Los Angeles, CA, US · Registration 3011845821

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011845821
FEI Number
3011845821
Entity Name
NEUROSIGMA, INC.
City/State/Country
Los Angeles, CA, US
Establishment Address
10960 Wilshire Blvd., Suite 1910, Los Angeles, CA 90024, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
NeuroSigma, Inc. (Owner Number: 10060896)
Owner / Operator Contact Address
10960 Wilshire Blvd., Suite 1910, Los Angeles, CA 90024, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K233293
PMA Number
N/A

All Registered Proprietary Names

Monarch eTNS System Monarch NS-2 Electric Patch Generation 2 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QGL Transcutaneous Nerve Stimulator For Adhd Neurology Class 2 882.5898 2019-07-09
QGL Transcutaneous Nerve Stimulator For Adhd Neurology Class 2 882.5898 2024-08-15

Official Correspondent

Patrick Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeuroSigma, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011845821. Last updated year: 2026. Please use registration number 3011845821 when referencing this establishment in official correspondence.
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