510(k) K852704

TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT by Clincal Instruments Corp. — Product Code HGM

K852704 is an FDA 510(k) premarket notification submitted by Clincal Instruments Corp. for the device "TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT". The FDA issued a decision of Substantially Equivalent on November 26, 1985. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Clincal Instruments Corp. has at least 7 other 510(k) clearances on record.