510(k) K201628

Panda iRes Warmer, Giraffe Warmer by GE Healthcare — Product Code FMT

K201628 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Panda iRes Warmer, Giraffe Warmer". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. GE Healthcare has at least 10 other 510(k) clearances on record.