GE OEC EVERVIEW 7500

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 Ge Oec Everview 7500.

Pre-market Notification Details

Device IDK051490
510k NumberK051490
Device Name:GE OEC EVERVIEW 7500
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant GE OEC MEDICAL SYSTEMS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactSusan Schmidt
CorrespondentSusan Schmidt
GE OEC MEDICAL SYSTEMS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-06
Decision Date2005-07-07
Summary:summary

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