De Novo DEN140038
- Device
- Dexcom Share Direct Secondary Displays
- Contact
- andrew k balo
- De Novo number
- DEN140038
- Product code
- PJT
- Regulation
- 862.1350
- Classification name
- continuous glucose monitor secondary display
- Decision
- granted (DENG)
- Decision date
- 2015-01-23
- Date received
- 2014-12-15
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- PJT
- Device name
- Continuous Glucose Monitor Secondary Display
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1350
- Implant
- N
- Life sustain/support
- N