VIVID T8/VIVID T8 PRO

System, Imaging, Pulsed Doppler, Ultrasonic

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Vivid T8/vivid T8 Pro.

Pre-market Notification Details

Device IDK141067
510k NumberK141067
Device Name:VIVID T8/VIVID T8 PRO
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE HEALTHCARE 9900 Innovation Drive Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE HEALTHCARE 9900 Innovation Drive Wauwatosa,  WI  53226
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-24
Decision Date2014-05-23
Summary:summary

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