FibroScan® Family Of Products (Models: 502 Touch, 530 Compact, 430 Mini+, And 630)

System, Imaging, Pulsed Echo, Ultrasonic

Echosens

The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan® Family Of Products (models: 502 Touch, 530 Compact, 430 Mini+, And 630).

Pre-market Notification Details

Device IDK203273
510k NumberK203273
Device Name:FibroScan® Family Of Products (Models: 502 Touch, 530 Compact, 430 Mini+, And 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-06
Decision Date2021-03-25

Trademark Results [FibroScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIBROSCAN
FIBROSCAN
79094348 4072585 Live/Registered
ECHOSENS
2011-01-27
FIBROSCAN
FIBROSCAN
79016519 3209344 Live/Registered
ECHOSENS
2005-08-25
FIBROSCAN
FIBROSCAN
74721757 not registered Dead/Abandoned
Immunomedics, Inc.
1995-08-28
FIBROSCAN
FIBROSCAN
74214670 not registered Dead/Abandoned
IMMUNOMEDICS, INC.
1991-10-23

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