CURA 778

System, X-ray, Tomography, Computed

FMI Medical Systems Inc.

The following data is part of a premarket notification filed by Fmi Medical Systems Inc. with the FDA for Cura 778.

Pre-market Notification Details

Device IDK192590
510k NumberK192590
Device Name:CURA 778
ClassificationSystem, X-ray, Tomography, Computed
Applicant FMI Medical Systems Inc. 29001 Solon Road, Unit A Solon,  OH  44139
ContactDazhuang Meng
CorrespondentDazhuang Meng
FMI Medical Systems Inc. 29001 Solon Road, Unit A Solon,  OH  44139
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2020-03-05

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