510(k) K002355

ATOM INFA WARMER V-505 by Atom Medical Corp — Product Code FMT

K002355 is an FDA 510(k) premarket notification submitted by Atom Medical Corp for the device "ATOM INFA WARMER V-505". The FDA issued a decision of Substantially Equivalent on October 10, 2000. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Atom Medical Corp has at least 4 other 510(k) clearances on record.