AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM – SINGLE PATIENT, 1 TO 3 STATION


Device Classification Name

subsystem, water purification

510(k) Number K111740
Device Name AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM – SINGLE PATIENT, 1 TO 3 STATION
Applicant
AMERIWATER
1303 stanley ave.
dayton, 
OH 
45404

Applicant Contact brian r bowman
Correspondent
AMERIWATER
1303 stanley ave.
dayton, 
OH 
45404

Correspodent Contact brian r bowman
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 06/21/2011
Decision Date 10/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls