510(k) K012003

DRG REACTION CHAMBER/SAFETY TIP by Doctor'S Research Group, Inc. — Product Code HEI

K012003 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "DRG REACTION CHAMBER/SAFETY TIP". The FDA issued a decision of Substantially Equivalent on February 12, 2002. The device falls under product code HEI (Monitor, Heart-Valve Movement, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.