AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS


Device Classification Name

subsystem, water purification

510(k) Number K991519
Device Name AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
AMERIWATER
1257 stanley ave.
dayton, 
OH 
45404

Applicant Contact sandra e monsman
Correspondent
AMERIWATER
1257 stanley ave.
dayton, 
OH 
45404

Correspodent Contact sandra e monsman
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 04/30/1999
Decision Date 04/14/2000
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