510(k) K203114

LOGIQ P10, LOGIQ P9, LOGIQ P8 by GE Medical Systems Ultrasound And Primary Care Diagnostics — Product Code IYN

K203114 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics for the device "LOGIQ P10, LOGIQ P9, LOGIQ P8". The FDA issued a decision of Substantially Equivalent on Jan 8, 2021. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. GE Medical Systems Ultrasound And Primary Care Diagnostics has 82 other 510(k) clearances on record.