510(k) DEN190047
- Device
- CADScor System
- Applicant
- Acarix A/S
- 510(k) number
- DEN190047
- Product code
- QMW
- Decision
- Unknown (DENG)
- Decision date
- 2020-11-24
- Date received
- 2019-11-04
- Regulation
- 870.1420
- Classification name
- Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mette Munch
- Address
- Ryvangs Alle 81 Hellerup DK 2900 2900
FDA Registration Numbers#
- 3013791928
- 3008773490
- 3019252624
Source Documents#
510(k) summary PDF not indicated by FDA