Cleared Traditional

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM

K121341 · Fresenius Medical Care North America · Gastroenterology & Urology

Dec 2012

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K121341 is an FDA 510(k) clearance for the FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM, 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 6, 2012, 217 days after receiving the submission on May 3, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K121341 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2012
Decision Date	December 06, 2012
Days to Decision	217 days
Submission Type	Traditional
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