510(k) K050601

SMARTDOP 45 VASCULAR DOPPLER by Koven Technology, Inc. — Product Code DPW

K050601 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "SMARTDOP 45 VASCULAR DOPPLER". The FDA issued a decision of Substantially Equivalent on April 15, 2005. 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.