LOGIQ P10, LOGIQ P9, LOGIQ P8

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 Logiq P10, Logiq P9, Logiq P8.

Pre-market Notification Details

Device IDK203114
510k NumberK203114
Device Name:LOGIQ P10, LOGIQ P9, LOGIQ P8
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics ,LLC 9900 Innovation Dr. Wauwatosa,  WI  53226
ContactBryan Behn
CorrespondentBryan Behn
GE Medical Systems Ultrasound And Primary Care Diagnostics ,LLC 9900 Innovation Dr. 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 Received2020-10-15
Decision Date2021-01-08

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