510(k) DEN180041
DEN180041 is an FDA 510(k) premarket notification submitted by Neurosigma, Inc. for the device "Monarch eTNS System". The FDA issued a decision of De Novo Granted on April 19, 2019. The device falls under product code QGL (Transcutaneous Nerve Stimulator For Adhd), a Class II device regulated under 21 CFR 882.5898. Neurosigma, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 19, 2019
- Date Received
- July 30, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcutaneous Nerve Stimulator For Adhd
- Device Class
- Class II
- Regulation Number
- 882.5898
- Review Panel
- NE
- Submission Type
A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.