Vivid E80, Vivid E90, Vivid E95

System, Imaging, Pulsed Doppler, Ultrasonic

GE Medical Systems Ultrasound And

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

Pre-market Notification Details

Device IDK220882
510k NumberK220882
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
CorrespondentLee Bush
GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. 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 Received2022-03-25
Decision Date2022-07-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195278388483 K220882 000

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