MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS


Device Classification Name

subsystem, water purification

510(k) Number K021560
Device Name MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Original Applicant
AMERIWATER
1257 stanley ave.
dayton, 
OH 
45404

Original Contact brain r bowman
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 05/13/2002
Decision Date 08/14/2003
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