Transducer, Ultrasonic, Diagnostic


The following data is part of a premarket notification filed by Medxpress.pro with the FDA for Ez-cover.

Pre-market Notification Details

Device IDK191491
510k NumberK191491
Device Name:EZ-Cover
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant MedXPress.Pro Slachthuislaan 1, Bus 102 Leuven,  BE 3000
ContactKatherine Hughey
CorrespondentJeff Kasoff
Lean To Quality, LLC 107 Avenue A Willis,  TX  77378
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-05
Decision Date2020-06-05

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