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KPF — System, Dialysate Delivery, Semi-Automatic, Peritoneal Class II

FDA Device Classification

Classification Details

Product Code
KPF
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K061515baxter healthcareRENALSOFTSeptember 11, 2006
K990953baxter healthcareRENAL LINKJune 18, 1999
K970989cybernius medicalCYBERRENJuly 24, 1997
K955762fresenius usaPACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMJuly 31, 1996
K913515dencoTOTAL CONTAINMENT DEVICEMay 26, 1994
K875121amiconAMICON EQUALINE FLUID BALANCE SYSTEMFebruary 19, 1988
K874020abbott laboratoriesULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICEJanuary 29, 1988
K821328medionics internationalC.A.P.D. AUTOMATIC HEATER #PDC 2000 HCPJuly 28, 1982
K802831gambroGAMBRO PERITONEAL DIALYSIS MONITORDecember 18, 1980
K800496american medical productsCYCLER W/5 OR 10 HR. FILL/DWELL TIMERJuly 21, 1980
K791676j.m. sounds electronicsPERITONEAL DIALYSIS CYCLER MODEL PDC1000December 6, 1979
K791584american medical productsCYLER/HEATER FOR PERITONEAL DIALYSISNovember 16, 1979
K790091american medical productsAMP AUTOMATIC CYCLER STANDFebruary 16, 1979