FibroScan® 630

System, Imaging, Pulsed Echo, Ultrasonic


The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan® 630.

Pre-market Notification Details

Device IDK200655
510k NumberK200655
Device Name:FibroScan® 630
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Echosens 6 Rue Ferrus Paris,  FR 75014
ContactKarine Bonenfant
CorrespondentZvi Ladin
Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 Dedham,  MA  02026
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-12
Decision Date2020-07-16

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