510(k) K173941

IntelliSpace Perinatal Rev.K.00 by Philips Medizin Systeme Boeblingen GmbH — Product Code HGM

K173941 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "IntelliSpace Perinatal Rev.K.00". The FDA issued a decision of Substantially Equivalent on September 10, 2018. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Philips Medizin Systeme Boeblingen GmbH has at least 10 other 510(k) clearances on record.