510(k) K213974

GEM FLOW COUPLER Monitor (GEM1020M-2) by Synovis Micro Companies Alliance, Inc. — Product Code DPW

K213974 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance, Inc. for the device "GEM FLOW COUPLER Monitor (GEM1020M-2)". The FDA issued a decision of Substantially Equivalent on April 20, 2022. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Synovis Micro Companies Alliance, Inc. has at least 4 other 510(k) clearances on record.