Cleared Special

FRESENIUS 2008T HEMODIALYSIS MACHINE

K113427 · Fresenius Medical Care North America · Gastroenterology & Urology

Dec 2011

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K113427 is an FDA 510(k) clearance for the FRESENIUS 2008T HEMODIALYSIS MACHINE, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care North America (Waltham,, US). The FDA issued a Cleared decision on December 21, 2011, 30 days after receiving the submission on November 21, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K113427 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2011
Decision Date	December 21, 2011
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860