CardioVision— 510(k) K251293
Substantially EquivalentIcardio.Ai
FDA 510(k) clearance K251293 for CardioVision, Substantially Equivalent on 2025-11-21. Applicant: Icardio.Ai. Device class: 2.
Clearance details
- Applicant
- Icardio.Ai
- Product code
- Code QUO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Hollywood, CA, US
Recent devices under product code QUO
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