510(k) K861189

TECNOL SECURE-ALL FETAL MONITOR STRAP by Tecnol New Jersey Wound Care, Inc. — Product Code HGM

K861189 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL SECURE-ALL FETAL MONITOR STRAP". The FDA issued a decision of Substantially Equivalent on April 8, 1986. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.