UROVIEW MODEL 2600

System, X-ray, Fluoroscopic, Image-intensified

GE DEC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Uroview Model 2600.

Pre-market Notification Details

Device IDK940295
510k NumberK940295
Device Name:UROVIEW MODEL 2600
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactThomas R Meyers
CorrespondentThomas R Meyers
GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-21
Decision Date1994-08-22

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