510(k) K140623

NXSTAGE EXPRESS FLUID WARMER by Nxstage Medical, Inc. — Product Code FLA

K140623 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NXSTAGE EXPRESS FLUID WARMER". The FDA issued a decision of Substantially Equivalent on June 16, 2014. The device falls under product code FLA (Monitor, Temperature, Dialysis), a Class II device regulated under 21 CFR 876.5820. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.