Us2.ca— 510(k) K250151
Substantially EquivalentEko.Ai Pte Ltd. D/B/A Us2.Ai
FDA 510(k) clearance K250151 for Us2.ca, Substantially Equivalent on 2025-06-20. Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai.
Clearance details
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Product code
- Code SDJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Data sourced from openFDA. This site is unofficial and independent of the FDA.