510(k) K994353

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 by Precision Dynamics Corp. — Product Code HFM

K994353 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565". The FDA issued a decision of Substantially Equivalent on March 22, 2000. 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. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.