510(k) K010452

BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T by Koven Technology, Inc. — Product Code DPW

K010452 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T". The FDA issued a decision of Substantially Equivalent on February 12, 2002. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Koven Technology, Inc. has at least 10 other 510(k) clearances on record.