510(k) K182859

Babyleo TN500 by Dragerwerk AG & CO Kgaa — Product Code FMZ

K182859 is an FDA 510(k) premarket notification submitted by Dragerwerk AG & CO Kgaa for the device "Babyleo TN500". The FDA issued a decision of Substantially Equivalent on February 22, 2019. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Dragerwerk AG & CO Kgaa has at least 1 other 510(k) clearance on record.