GE DEFINIUM AMX 700, MODEL AMX 700

System, X-ray, Mobile

GENERAL ELECTRIC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by General Electric Medical Systems with the FDA for Ge Definium Amx 700, Model Amx 700.

Pre-market Notification Details

Device IDK052897
510k NumberK052897
Device Name:GE DEFINIUM AMX 700, MODEL AMX 700
ClassificationSystem, X-ray, Mobile
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS P.O. BOX 414 Milwaukee,  WI 
ContactMark Stauffer
CorrespondentMark Stauffer
GENERAL ELECTRIC MEDICAL SYSTEMS P.O. BOX 414 Milwaukee,  WI 
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-14
Decision Date2005-11-08
Summary:summary

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