Vivid E80, Vivid E90, Vivid E95

System, Imaging, Pulsed Doppler, Ultrasonic

GE Medical Systems Ultrasound And Primary Care Diagnostics,

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics, with the FDA for Vivid E80, Vivid E90, Vivid E95.

Pre-market Notification Details

Device IDK181685
510k NumberK181685
Device Name:Vivid E80, Vivid E90, Vivid E95
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics, 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 Received2018-06-26
Decision Date2018-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682141710 K181685 000
00840682143189 K181685 000
00840682141734 K181685 000
00840682141727 K181685 000
00840682141550 K181685 000
00840682141543 K181685 000
00840682141536 K181685 000

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