Skip to contentDe Novo DEN190047
- Device
- CADScor System
- Contact
- mette munch
- De Novo number
- DEN190047
- Product code
- QMW
- Regulation
- 870.1420
- Classification name
- coronary artery disease risk indicator from acoustic heart signals
- Decision
- granted (DENG)
- Decision date
- 2020-11-24
- Date received
- 2019-11-04
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QMW
- Device name
- Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.1420
- Implant
- N
- Life sustain/support
- N