510(k) K181991

NxStage Connected Health System by Nxstage Medical, Inc. — Product Code FKP

K181991 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NxStage Connected Health System". The FDA issued a decision of Substantially Equivalent on September 26, 2018. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.