510(k) K080226

NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 by Hill-Rom Manufacturing, Inc. — Product Code HGM

K080226 is an FDA 510(k) premarket notification submitted by Hill-Rom Manufacturing, Inc. for the device "NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912". The FDA issued a decision of Substantially Equivalent on April 9, 2008. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Hill-Rom Manufacturing, Inc. has at least 3 other 510(k) clearances on record.