SERIES 6600 DIGITAL MOBILE C-ARM

Image-intensified Fluoroscopic X-ray System, Mobile

GE DEC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Series 6600 Digital Mobile C-arm.

Pre-market Notification Details

Device IDK951765
510k NumberK951765
Device Name:SERIES 6600 DIGITAL MOBILE C-ARM
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactTed L Parrot
CorrespondentTed L Parrot
GE DEC MEDICAL SYSTEMS 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 Received1995-04-17
Decision Date1995-05-11
Summary:summary

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