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510k Database
Manufacturers
SG
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Medical Device Manufacturer
·
SG , Singapore
Eko.Ai Pte Ltd. D/B/A Us2.Ai - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
Recent clearances:
Us2.ca
,
Us2.v2
,
Us2.v1
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eko.Ai Pte Ltd. D/B/A Us2.Ai
Cardiovascular
✕
1
devices
1-1 of 1
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Cleared
Jun 20, 2025
Us2.ca
K250151
·
SDJ
Cardiovascular
·
150d
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Radiology
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Cardiovascular
1