Us2.v1— 510(k) K210791
Substantially EquivalentEko.Ai Pte Ltd. D/B/A Us2.Ai
FDA 510(k) clearance K210791 for Us2.v1, Substantially Equivalent on 2021-07-27. 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.