510(k) K013376

QFLOW 500 PERFUSION MONITORING SYSTEM by Hemedex Incorporated — Product Code DPW

K013376 is an FDA 510(k) premarket notification submitted by Hemedex Incorporated for the device "QFLOW 500 PERFUSION MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 8, 2002. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Hemedex Incorporated has at least 3 other 510(k) clearances on record.