510(k) K050088

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER by Neoprobe Corp. — Product Code DPW

K050088 is an FDA 510(k) premarket notification submitted by Neoprobe Corp. for the device "QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER". The FDA issued a decision of Substantially Equivalent on February 8, 2005. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Neoprobe Corp. has at least 5 other 510(k) clearances on record.