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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
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 01, 2024
Us2.v2
K233676
·
QIH
Radiology
·
137d
Cleared
Jul 27, 2021
Us2.v1
K210791
·
QIH
Radiology
·
133d
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3
Radiology
2
Cardiovascular
1