OEC FLUOROTRAK 9800 PLUS

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 Fluorotrak 9800 Plus.

Pre-market Notification Details

Device IDK022069
510k NumberK022069
Device Name:OEC FLUOROTRAK 9800 PLUS
ClassificationInterventional Fluoroscopic X-ray System
Applicant GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactBill Gislason
CorrespondentBill Gislason
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 Received2002-06-25
Decision Date2002-09-17
Summary:summary

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