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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 K193518
Device Name KOSMOS
Applicant
EchoNous, Inc.
8310 154th Ave NE, Bldg B, Ste 200
Redmond,  WA  98052
Applicant Contact Trish Liau
Correspondent
EchoNous, Inc.
8310 154th Ave NE, Bldg B, Ste 200
Redmond,  WA  98052
Correspondent Contact Trish Liau
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DPS   DQD   ITX   IYO  
Date Received12/19/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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