510(k) K173516

NuBorne Infant Warmer by International Biomedical — Product Code FMT

K173516 is an FDA 510(k) premarket notification submitted by International Biomedical for the device "NuBorne Infant Warmer". The FDA issued a decision of Substantially Equivalent on August 17, 2018. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. International Biomedical has at least 10 other 510(k) clearances on record.