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FKP — System, Dialysate Delivery, Single Patient Class II

FDA Device Classification

Classification Details

Product Code
FKP
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181991nxstage medicalNxStage Connected Health SystemSeptember 26, 2018
K131739nxstage medicalNXSTAGE CONNECTED HEALTH SYSTEMOctober 10, 2013
K130460nxstage medicalNXSTAGE DOSING CALCULATORJuly 11, 2013
K040074nxstage medicalONEVIEW INTERFACEApril 8, 2004
K021060fresenius medical care north americaFRESENIUS ICARE MONITORING SYSTEMNovember 13, 2002
K003615environmental test systemsSTERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSFebruary 1, 2001
K992255csamCKHEMO, MODEL CKHEMO VERSION 1.0November 30, 1999
K964264integrated biomedical technologyHIGH RANGE PEROXIDE TEST STRIPJune 16, 1997
K955423fresenius usaPACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMJune 13, 1996
K953854integrated biomedical technologyWATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDEMarch 11, 1996
K930181fresenius usaBIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATENovember 29, 1995
K922757baxter healthcareSPS 1550 SINGLE NEEDLE PATIENT SYSTEMFebruary 13, 1995
K921456fresenius usaFRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEMApril 20, 1994
K910215cd medicalDRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTApril 9, 1991
K905793cobe laboratoriesCOBE CENTRY 2 BICART OPTION KITFebruary 12, 1991
K905388cobe laboratoriesCOBE CENTRYSYSTEM 3 BICART OPTION KITFebruary 11, 1991
K904967gambro-hosp-cobeHOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIALJanuary 28, 1991
K896758gambroGAMBRO BICARBONATE MONITOR BCM 10-3September 28, 1990
K896757gambroGAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSAugust 30, 1990
K894838baxter healthcareHEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSBSeptember 7, 1989