De Novo DEN250046
- Device
- Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
- Contact
- luuk giesen
- De Novo number
- DEN250046
- Product code
- SIW
- Regulation
- 880.6975
- Classification name
- robotic peripheral venous blood collection system
- Decision
- granted (DENG)
- Decision date
- 2026-08-19
- Date received
- 2025-09-26
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct