510(k) K970074

STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) by Hill-Rom, Inc. — Product Code FMT

K970074 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)". The FDA issued a decision of Substantially Equivalent on April 3, 1997. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.