FRESENIUS 2008T HEMODIALYSIS MACHINE


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K111639
Device Name FRESENIUS 2008T HEMODIALYSIS MACHINE
Applicant
FRESENIUS MEDICAL CARE
920 winter street
waltham, 
MA 
02451

Applicant Contact denise oppermann
Correspondent
FRESENIUS MEDICAL CARE
920 winter street
waltham, 
MA 
02451

Correspodent Contact denise oppermann
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 06/13/2011
Decision Date 10/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls