510(k) K243606

Babyroo TN300 by Draeger Medical Systems, Inc. — Product Code FMT

K243606 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "Babyroo TN300". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.