De Novo DEN150048
- Device
- gammaCore Non-invasive Vagus Nerve Stimulator
- Contact
- mike romaniw
- De Novo number
- DEN150048
- Product code
- PKR
- Regulation
- 882.5892
- Classification name
- non-invasive vagus nerve stimulator - headache
- Decision
- granted (DENG)
- Decision date
- 2017-04-14
- Date received
- 2015-10-16
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- PKR
- Device name
- Non-Invasive Vagus Nerve Stimulator - Headache
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5892
- Implant
- N
- Life sustain/support
- N