510(k) K894030

MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR by Healthdyne, Inc. — Product Code HFM

K894030 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.