510(k) K935609

4002 INFANT SCALE FOR INCUBATORS AND WARMERS by Scale-Tronix, Inc. — Product Code FMT

K935609 is an FDA 510(k) premarket notification submitted by Scale-Tronix, Inc. for the device "4002 INFANT SCALE FOR INCUBATORS AND WARMERS". The FDA issued a decision of Substantially Equivalent on July 1, 1994. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Scale-Tronix, Inc. has at least 3 other 510(k) clearances on record.