GE LOGIQ I, LOGIQ E AND VIVID E

System, Imaging, Pulsed Doppler, Ultrasonic

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Logiq I, Logiq E And Vivid E.

Pre-market Notification Details

Device IDK113690
510k NumberK113690
Device Name:GE LOGIQ I, LOGIQ E AND VIVID E
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa,  WI  53226
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-15
Decision Date2011-12-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682110310 K113690 000
00840682110235 K113690 000

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