510(k) K203137

Venue Fit by GE Medical Systems Ultrasound And Primary Care Diagnostics — Product Code IYN

K203137 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics for the device "Venue Fit". The FDA issued a decision of Substantially Equivalent on Dec 29, 2020. 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.