GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

GE VINGMED ULTRASOUND AS

The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Vivid E9 Diagnostic Ultrasound Imaging System.

Pre-market Notification Details

Device IDK120201
510k NumberK120201
Device Name:GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR., RP-2138 Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR., RP-2138 Wauwatosa,  WI  53226
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-23
Decision Date2012-04-19
Summary:summary

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