Us2.v2— 510(k) K233676
Substantially EquivalentEko.Ai Pte Ltd. D/B/A Us2.Ai
FDA 510(k) clearance K233676 for Us2.v2, Substantially Equivalent on 2024-04-01. 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 QIH
- Advisory panel
- Radiology
- 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.