510(k) K200975

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum by Huntleigh Healthcare Limited — Product Code HGM

K200975 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare Limited for the device "Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum". The FDA issued a decision of Substantially Equivalent on June 24, 2020. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Huntleigh Healthcare Limited has at least 2 other 510(k) clearances on record.