Eko.Ai Pte Ltd. D/B/A Us2.Ai is one of 29 FDA 510(k) medical device manufacturers from Singapore in the dataset, ranked by real submission volume.
Eko.Ai Pte Ltd. D/B/A Us2.Ai has 3 FDA 510(k) cleared medical devices. Based in Singapore, SG.
Latest FDA clearance: Jun 2025. Active since 2021. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Eko.Ai Pte Ltd. D/B/A Us2.Ai Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Enzyme Corporation as regulatory consultant.
FDA 510(k) Regulatory Record - Eko.Ai Pte Ltd. D/B/A Us2.Ai
3 devices