FDA 510(k) Applications Submitted by Karine Bonenfant

FDA 510(k) Number Submission Date Device Name Applicant
K160524 02/25/2016 FibroScan 530 Compact ECHOSENS
K200655 03/12/2020 FibroScan« 630 Echosens
K181547 06/12/2018 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens
K212035 06/30/2021 FibroScan 230 Echosens
K172142 07/17/2017 FibroScan 430 Mini+ Echosens
K173034 09/28/2017 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens
K203273 11/06/2020 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) Echosens


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