De Novo DEN250057
- Device
- PCWP Analysis Software
- Contact
- arezou azar
- De Novo number
- DEN250057
- Product code
- SIF
- Regulation
- 870.1150
- Classification name
- software device system for estimation of cardiac pressures
- Decision
- granted (DENG)
- Decision date
- 2026-05-22
- Date received
- 2025-11-17
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct