FibroScan 430 Mini+

System, Imaging, Pulsed Echo, Ultrasonic

Echosens

The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan 430 Mini+.

Pre-market Notification Details

Device IDK172142
510k NumberK172142
Device Name:FibroScan 430 Mini+
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Echosens 30 Place D'Italie Paris,  FR 75013
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-17
Decision Date2017-09-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03662264001147 K172142 000

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