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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K212100
Device Name Kosmos
Applicant
EchoNous, Inc.
8310 154th Ave NE, Building B, Suite 200
Redmond,  WA  98052
Applicant Contact Carly Hom
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DPS   DQD   ITX   IYO  
Date Received07/06/2021
Decision Date 08/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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