510(k) K882138

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER by Imex Medical Systems, Inc. — Product Code DPW

K882138 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER". The FDA issued a decision of Substantially Equivalent on November 7, 1988. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.