OEC(R) 9800, OEC(R) 9800 PLUS

Interventional Fluoroscopic X-ray System

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(r) 9800, Oec(r) 9800 Plus.

Pre-market Notification Details

Device IDK111551
510k NumberK111551
Device Name:OEC(R) 9800, OEC(R) 9800 PLUS
ClassificationInterventional Fluoroscopic X-ray System
Applicant GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactGerald Buss
CorrespondentGerald Buss
GE OEC MEDICAL SYSTEMS, INC 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 Received2011-06-03
Decision Date2011-10-04
Summary:summary

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