510(k) K003335

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER by Hill-Rom Air-Shields — Product Code FMT

K003335 is an FDA 510(k) premarket notification submitted by Hill-Rom Air-Shields for the device "RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER". The FDA issued a decision of Substantially Equivalent on November 17, 2000. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Hill-Rom Air-Shields has at least 4 other 510(k) clearances on record.