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De Novo DEN180055
- Device
- CARPEDIEM System
- Contact
- matteo chiappini
- De Novo number
- DEN180055
- Product code
- QIR
- Regulation
- 876.5861
- Classification name
- pediatric hemodialysis system
- Decision
- granted (DENG)
- Decision date
- 2020-04-29
- Date received
- 2018-10-09
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QIR
- Device name
- Pediatric Hemodialysis System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5861
- Implant
- N
- Life sustain/support
- Y