Cleared Traditional

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

K955762 · Fresenius USA, Inc. · Gastroenterology & Urology
Jul 1996
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K955762 is an FDA 510(k) clearance for the PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM, a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II — Special Controls, product code KPF), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on July 31, 1996, 226 days after receiving the submission on December 18, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K955762 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1995
Decision Date July 31, 1996
Days to Decision 226 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KPF — System, Dialysate Delivery, Semi-automatic, Peritoneal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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