Vivid T8, Vivid T9

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 T8, Vivid T9.

Pre-market Notification Details

Device IDK200851
510k NumberK200851
Device Name:Vivid T8, Vivid T9
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics 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 Received2020-03-31
Decision Date2020-09-09

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