CADScor System
FDA 510(k) clearance DEN190047 · decided 2020-11-24
Clearance details
- K-number
- DEN190047
- Device name
- CADScor System
- Applicant
- Acarix A/S
- Decision
- Unknown
- Date received
- 2019-11-04
- Decision date
- 2020-11-24
- Days to decision
- 386 days
- Clearance type
- Direct
- Product code
- QMW
- Device class
- 2
- Regulation number
- 870.1420
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hellerup, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.