De Novo DEN260007
- Device
- SmartRead(TM) Medical Device Identifier (4100)
- Contact
- john walmsley
- De Novo number
- DEN260007
- Product code
- SJJ
- Regulation
- 870.3645
- Classification name
- cardiac device identifier
- Decision
- granted (DENG)
- Decision date
- 2026-09-29
- Date received
- 2026-03-24
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct