Cleared Special

K080964 - FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
(FDA 510(k) Clearance)

K080964 · Fresenius Medical Care North America · Gastroenterology & Urology

Jan 2009

Decision

285d

Days

Class 2

Risk

K080964 is an FDA 510(k) clearance for the FRESENIUS MODEL 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 January 14, 2009, 285 days after receiving the submission on April 4, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K080964 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2008
Decision Date	January 14, 2009
Days to Decision	285 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