PORTABLE RO+ MODEL MROS09


Device Classification Name

subsystem, water purification

510(k) Number K030059
Device Name PORTABLE RO+ MODEL MROS09
Original Applicant
AMERIWATER
1257 stanley ave.
dayton, 
OH 
45404

Original Contact brian r bowman
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 01/07/2003
Decision Date 04/07/2003
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