510(k) K840285

NON STRESS TEST MONITOR 507 by Imex Medical Systems, Inc. — Product Code HGH

K840285 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "NON STRESS TEST MONITOR 507". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.