510(k) K942243

IMEX 8000 PERSONAL CASCULAR LAB by Imex Medical Systems, Inc. — Product Code IYO

K942243 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "IMEX 8000 PERSONAL CASCULAR LAB". The FDA issued a decision of Substantially Equivalent on November 3, 1995. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.