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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 echo, ultrasonic
510(k) Number K203273
Device Name FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
Applicant
Echosens
6 rue Ferrus
Paris,  FR 75014
Applicant Contact Karine Bonenfant
Correspondent
Boston MedTech Advisors, Inc.
990 Washington Street, Suite 204
Dedham,  MA  02026
Correspondent Contact Zvi Ladin
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/06/2020
Decision Date 03/25/2021
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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