510(k) K933816

SONICAID MODEL P110 FETAL HEAR DETECTOR by Oxford Instruments, Plc. — Product Code HEL

K933816 is an FDA 510(k) premarket notification submitted by Oxford Instruments, Plc. for the device "SONICAID MODEL P110 FETAL HEAR DETECTOR". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Oxford Instruments, Plc. has at least 6 other 510(k) clearances on record.