De Novo DEN170078
- Device
- Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
- Contact
- ahava stein
- De Novo number
- DEN170078
- Product code
- QCI
- Regulation
- 882.5802
- Classification name
- transcranial magnetic stimulation system for obsessive-compulsive disorder
- Decision
- granted (DENG)
- Decision date
- 2018-08-17
- Date received
- 2017-09-29
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QCI
- Device name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5802
- Implant
- N
- Life sustain/support
- N