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De Novo DEN140033
- Device
- Companion
- Contact
- mike girouard
- De Novo number
- DEN140033
- Product code
- POS
- Regulation
- 882.1580
- Classification name
- physiological signal based seizure monitoring system
- Decision
- granted (DENG)
- Decision date
- 2017-02-16
- Date received
- 2014-11-10
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- POS
- Device name
- Physiological Signal Based Seizure Monitoring System
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.1580
- Implant
- N
- Life sustain/support
- N