FDA 510(k) Applications for Medical Device Product Code: FKP (System, Dialysate Delivery, Single Patient)

FDA 510(k) Applications for Medical Device Product Code "FKP"
(System, Dialysate Delivery, Single Patient)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K992255	CSAM, INC.	CKHEMO, MODEL CKHEMO VERSION 1.0	11/30/1999
K003615	ENVIRONMENTAL TEST SYSTEMS, INC.	STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS	02/01/2001
K021060	FRESENIUS MEDICAL CARE NORTH AMERICA	FRESENIUS ICARE MONITORING SYSTEM	11/13/2002
K955423	FRESENIUS USA, INC.	PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	06/13/1996
K964264	INTEGRATED BIOMEDICAL TECHNOLOGY, INC.	HIGH RANGE PEROXIDE TEST STRIP	06/16/1997
K953854	INTEGRATED BIOMEDICAL TECHNOLOGY, INC.	WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE	03/11/1996
K181991	NxStage Medical, Inc	NxStage Connected Health System	09/26/2018
K131739	NXSTAGE MEDICAL, INC.	NXSTAGE CONNECTED HEALTH SYSTEM	10/10/2013
K130460	NXSTAGE MEDICAL, INC.	NXSTAGE DOSING CALCULATOR	07/11/2013
K040074	NXSTAGE MEDICAL, INC.	ONEVIEW INTERFACE	04/08/2004