510(k) K974248

WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM by Air-Shields, Inc. — Product Code HGM

K974248 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 7, 1998. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Air-Shields, Inc. has at least 10 other 510(k) clearances on record.