510(k) K920333

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR by Koven and Assoc., Inc. — Product Code DPW

K920333 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR". The FDA issued a decision of Substantially Equivalent on January 22, 1993. 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.