510(k) K915550

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR by Koven and Assoc., Inc. — Product Code DPW

K915550 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR". The FDA issued a decision of Substantially Equivalent on December 10, 1992. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Koven and Assoc., Inc. has at least 7 other 510(k) clearances on record.