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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 K240406
Device Name Sonio Detect
Applicant
Sonio
17 Rue du Faubourg Montmartre
Paris,  FR 75009
Applicant Contact Florian Akpakpa
Correspondent
Sonio
17 Rue du Faubourg Montmartre
Paris,  FR 75009
Correspondent Contact Florian Akpakpa
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received02/09/2024
Decision Date 04/26/2024
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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