510(k) DEN180041
- Device
- Monarch eTNS System
- Applicant
- Neurosigma, Inc.
- 510(k) number
- DEN180041
- Product code
- QGL
- Decision
- Unknown (DENG)
- Decision date
- 2019-04-19
- Date received
- 2018-07-30
- Regulation
- 882.5898
- Classification name
- Transcutaneous Nerve Stimulator For Adhd
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ian A. Cook
- Address
- 10960 Wilshire Blvd., Suite 1910 Los Angeles CA US 90024 90024
FDA Registration Numbers#
- 3015946733
- 3006179052
- 3011845821
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QGL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243289 | ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. | 2025-01-16 |
| K232991 | BT-1000 | Bistos Co., Ltd. | 2024-08-28 |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | 2024-01-16 |
| K213629 | SMILE | Nu Eyne Co., Ltd. | 2023-02-12 |