510(k) K891997

CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER by Corometrics Medical Systems, Inc. — Product Code HFM

K891997 is an FDA 510(k) premarket notification submitted by Corometrics Medical Systems, Inc. for the device "CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER". The FDA issued a decision of Substantially Equivalent on June 8, 1989. 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. Corometrics Medical Systems, Inc. has at least 4 other 510(k) clearances on record.