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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 K260748
Device Name ES-Series
Applicant
E-Scopics
235 Rue Léon Foucault
Aix-En-Provence,  FR 13290
Applicant Contact Aurelie Gruener
Correspondent
E-Scopics
235 Rue Léon Foucault
Aix-En-Provence,  FR 13290
Correspondent Contact Aurelie Gruener
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/06/2026
Decision Date 06/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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