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De Novo DEN140016
- Device
- STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
- Contact
- andrew balo
- De Novo number
- DEN140016
- Product code
- PHV
- Regulation
- 862.2120
- Classification name
- continuous glucose monitor retrospective data analysis software
- Decision
- granted (DENG)
- Decision date
- 2014-08-19
- Date received
- 2014-04-22
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- PHV
- Device name
- Continuous Glucose Monitor Retrospective Data Analysis Software
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation
- 862.2120
- Implant
- N
- Life sustain/support
- N