FibroScan 230

System, Imaging, Pulsed Echo, Ultrasonic

Echosens

The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan 230.

Pre-market Notification Details

Device IDK212035
510k NumberK212035
Device Name:FibroScan 230
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-30
Decision Date2021-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03662264001222 K212035 000

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