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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 K230365
Device Name Sonio Detect
Applicant
Sonio
24 Rue du Faubourg Saint Jacques
Paris,  FR FR-75014
Applicant Contact Florian Akpakpa
Correspondent
Sonio
24 Rue du Faubourg Saint Jacques
Paris,  FR FR-75014
Correspondent Contact Florian Akpakpa
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received02/10/2023
Decision Date 07/25/2023
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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