FRESENIUS ICARE MONITORING SYSTEM


Device Classification Name

system, dialysate delivery, single patient

510(k) Number K021060
Device Name FRESENIUS ICARE MONITORING SYSTEM
Original Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 hayden ave.
lexington, 
MA 
02420 -9192

Original Contact nichole riek
Regulation Number 876.5820
Classification Product Code
FKP  
Date Received 04/02/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No