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De Novo DEN170043
- Device
- DreaMed Advisor Pro
- Contact
- eran atlas
- De Novo number
- DEN170043
- Product code
- QCC
- Regulation
- 862.1358
- Classification name
- insulin pump therapy adjustment calculator for healthcare professionals
- Decision
- granted (DENG)
- Decision date
- 2018-06-12
- Date received
- 2017-08-17
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- QCC
- Device name
- Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1358
- Implant
- N
- Life sustain/support
- N