510(k) K170714

Venue by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code IYN

K170714 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "Venue". The FDA issued a decision of Substantially Equivalent on Jun 21, 2017. 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 & Primary Care Diagnostics, LLC has 82 other 510(k) clearances on record.