BIOPURE PORTABLE RO SYSTEMS


Device Classification Name

subsystem, water purification

510(k) Number K112331
Device Name BIOPURE PORTABLE RO SYSTEMS
Applicant
ARION WATER, INC.
1 commerce way
bldg 1 unit c
carver, 
MA 
02330

Applicant Contact robert livingstion
Correspondent
ARION WATER, INC.
1 commerce way
bldg 1 unit c
carver, 
MA 
02330

Correspodent Contact robert livingstion
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 08/12/2011
Decision Date 07/05/2012
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