510(k) K233293
- Device
- Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
- Applicant
- Neurosigma, Inc.
- 510(k) number
- K233293
- Product code
- QGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-16
- Date received
- 2023-09-29
- Regulation
- 882.5898
- Classification name
- Transcutaneous Nerve Stimulator For Adhd
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Colin P. Kealey, M.D.
- Address
- 10960 Wilshire Blvd., Suite 1910 Los Angeles CA US 90024 90024
FDA Registration Numbers#
- 3015946733
- 3006179052
- 3011845821