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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
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