510(k) K003458

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 by Clinical Innovations, Inc. — Product Code HGP

K003458 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000". The FDA issued a decision of Substantially Equivalent on May 3, 2001. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Clinical Innovations, Inc. has at least 10 other 510(k) clearances on record.