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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 K200655
Device Name FibroScan® 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 Received03/12/2020
Decision Date 07/16/2020
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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