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De Novo DEN210003
- Device
- SureTune4 Software
- Contact
- teal bjoraker
- De Novo number
- DEN210003
- Product code
- QQC
- Regulation
- 882.5855
- Classification name
- brain stimulation programming planning software.
- Decision
- granted (DENG)
- Decision date
- 2021-08-23
- Date received
- 2021-02-03
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QQC
- Device name
- Brain Stimulation Programming Planning Software.
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5855
- Implant
- N
- Life sustain/support
- N