510(k) K230278

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

K230278 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 May 30, 2023. 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.