510(k) K251293
- Device
- CardioVision
- Applicant
- Icardio.Ai
- 510(k) number
- K251293
- Product code
- QUO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-21
- Date received
- 2025-04-25
- Regulation
- 870.2200
- Classification name
- Adjunctive Heart Failure Status Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Roman Sandler
- Address
- 8601 Beverly Blvd. Floor 2 West Hollywood CA US 90048 90048
FDA Registration Numbers#
- 2951215
- 3018772859
- 3016585383