GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND

System, Imaging, Pulsed Echo, Ultrasonic

GE MEDICAL SYSTEMS CHINA CO., LTD.

The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Ge Logiq I/e & Vivid E Compact Ultrasound.

Pre-market Notification Details

Device IDK091374
510k NumberK091374
Device Name:GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE Wuxi, Jiangsu Province,  CN 214028
ContactYalan Wu
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-05-11
Decision Date2009-05-26
Summary:summary

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