510(k) K233394

Gem Flow Now (GEM2770-FN) by Synovis Micro Companies Alliance — Product Code IYN

K233394 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance for the device "Gem Flow Now (GEM2770-FN)". The FDA issued a decision of Substantially Equivalent on January 28, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Synovis Micro Companies Alliance has at least 4 other 510(k) clearances on record.