OEC 9900 ELITE

Interventional Fluoroscopic X-ray System

GE OEC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Oec Medical Systems with the FDA for Oec 9900 Elite.

Pre-market Notification Details

Device IDK073543
510k NumberK073543
Device Name:OEC 9900 ELITE
ClassificationInterventional Fluoroscopic X-ray System
Applicant GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactMaria C Frame
CorrespondentMaria C Frame
GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-17
Decision Date2008-05-02
Summary:summary

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