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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 K233826
Device Name Kosmos
Applicant
EchoNous, Inc.
8310 154th Ave NE, Bldg B, Ste 200
Redmond,  WA  98052
Applicant Contact Joshua Kim
Correspondent
EchoNous, Inc.
8310 154th Ave NE, Bldg B, Ste 200
Redmond,  WA  98052
Correspondent Contact Joshua Kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DPS   DQD   ITX   IYO   QIH  
Date Received12/01/2023
Decision Date 08/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Clinical Trials NCT06027164
Reviewed by Third Party No
Combination Product No
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