K240653
- 510(k) number
- K240653
- Device name
- SmartCardia 7L Platform (MCT)
- Applicant
- Smartcardia SA CH
- Product code
- QYX — Outpatient Cardiac Telemetry
- Decision date
- 2024-10-31
- Date received
- 2024-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240653.pdf
Official FDA record: K240653
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.