UROVIEW 2800

Interventional Fluoroscopic X-ray System

GE DEC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Uroview 2800.

Pre-market Notification Details

Device IDK993687
510k NumberK993687
Device Name:UROVIEW 2800
ClassificationInterventional Fluoroscopic X-ray System
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 CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-01
Decision Date1999-12-21
Summary:summary

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