PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

System, Dialysate Delivery, Semi-automatic, Peritoneal

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Packpd Peritoneal Dialysis Urea Kinetic Modeling Software Program.

Pre-market Notification Details

Device IDK955762
510k NumberK955762
Device Name:PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
ClassificationSystem, Dialysate Delivery, Semi-automatic, Peritoneal
Applicant FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek,  CA  94598
ContactTom Folden
CorrespondentTom Folden
FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek,  CA  94598
Product CodeKPF  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-18
Decision Date1996-07-31

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