510(k) K234106

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

K234106 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 June 10, 2024. 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 at least 10 other 510(k) clearances on record.