510(k) K843011

TERM GUARD 5000 UTERINE ACTIVITY by Tokos Medical Corp. — Product Code HFM

K843011 is an FDA 510(k) premarket notification submitted by Tokos Medical Corp. for the device "TERM GUARD 5000 UTERINE ACTIVITY". The FDA issued a decision of Substantially Equivalent on November 1, 1984. 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. Tokos Medical Corp. has at least 1 other 510(k) clearance on record.