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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 K150949
Device Name FibroScan
Applicant
Echosens
30 Place D'Italie
Paris,  FR 75013
Applicant Contact CELINE FOURNIER
Correspondent
Boston Medtech Advisors, Inc.
990 Washington St., Suite 204
Dedham,  MA  02026
Correspondent Contact ZVI LADIN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/08/2015
Decision Date 06/03/2015
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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