K251293
- 510(k) number
- K251293
- Device name
- CardioVision
- Applicant
- Icardio.Ai CA · US
- Product code
- QUO — Adjunctive Heart Failure Status Indicator
- Decision date
- 2025-11-21
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251293.pdf
Official FDA record: K251293
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.