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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 K213102
Device Name ES1 System
Applicant
E-Scopics
931 Chemin De La Bosque D'Antonelle
Aix-En-Provence,  FR 13090
Applicant Contact Claude Cohen-Bacrie
Correspondent
E-Scopics
931 Chemin De La Bosque D'Antonelle
Aix-En-Provence,  FR 13090
Correspondent Contact Claude Cohen-Bacrie
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/24/2021
Decision Date 01/11/2022
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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