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532
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522
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490
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465
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510k Database
Manufacturers
US
EchoNous, Inc.
Medical Device Manufacturer
·
US , Redmond , VA
EchoNous, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2018
Recent clearances:
Kosmos
,
Kosmos
,
Kosmos
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - EchoNous, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Apr 25, 2025
Kosmos
K242321
·
IYN
Radiology
·
262d
Cleared
CT
Aug 29, 2024
Kosmos
K233826
·
IYN
Radiology
·
272d
Cleared
Aug 06, 2021
Kosmos
K212100
·
IYN
Radiology
·
31d
Cleared
Mar 26, 2020
KOSMOS
K193518
·
IYN
Radiology
·
98d
Cleared
Jul 10, 2018
Uscan
K181574
·
IYO
Radiology
·
25d
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5
Radiology
5