510(k) K182977

Isolette 8000 Plus by Draeger Medical Systems, Inc. — Product Code FMZ

K182977 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "Isolette 8000 Plus". The FDA issued a decision of Substantially Equivalent on November 21, 2018. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.