K233293
- 510(k) number
- K233293
- Device name
- Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
- Applicant
- Neurosigma, Inc. CA · US
- Product code
- QGL — Transcutaneous Nerve Stimulator For Adhd
- Decision date
- 2024-01-16
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233293.pdf
Official FDA record: K233293
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.