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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 K181547
Device Name FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Applicant
Echosens
30 Place D'Italie
Paris,  FR 75013
Applicant Contact Karine Bonenfant
Correspondent
Boston Medtech Advisors, Inc.
990 Washington St., Suite 204
Dedham,  MA  02026
Correspondent Contact Zvi Ladin
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received06/12/2018
Decision Date 07/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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