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De Novo DEN180041
- Device
- Monarch eTNS System
- Contact
- ian a. cook
- De Novo number
- DEN180041
- Product code
- QGL
- Regulation
- 882.5898
- Classification name
- transcutaneous nerve stimulator for adhd
- Decision
- granted (DENG)
- Decision date
- 2019-04-19
- Date received
- 2018-07-30
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QGL
- Device name
- Transcutaneous Nerve Stimulator For Adhd
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5898
- Implant
- N
- Life sustain/support
- N