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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 K242594
Device Name DEEPECHO
Applicant
DeepEcho
555 East Loockerman Street
Dover,  DE  19901
Applicant Contact Youssef Bouyakhf
Correspondent
DeepEcho
555 East Loockerman Street
Dover,  DE  19901
Correspondent Contact Youssef Bouyakhf
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received08/30/2024
Decision Date 05/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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