CardioVision— 510(k) K251293
Substantially EquivalentIcardio.Ai
FDA 510(k) clearance K251293 for CardioVision, Substantially Equivalent on 2025-11-21. Applicant: Icardio.Ai.
Clearance details
- Applicant
- Icardio.Ai
- Product code
- Code QUO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Hollywood, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.