OEC Elite

Image-intensified Fluoroscopic X-ray System, Mobile

GE OEC Medical Systems, Inc.

The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc. with the FDA for Oec Elite.

Pre-market Notification Details

Device IDK192819
501k NumberK192819
Device Name:OEC Elite
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City,  UT  84116
ContactKenny M Bello
CorrespondentKenny M Bello
GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City,  UT  84116
Product CodeOXO  
Subsequent Product CodeJAA
Subsequent Product CodeOWB
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2019-11-08

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