FDA 510(k) Applications for Medical Device Product Code: FIN (Tank, Holding, Dialysis)

FDA 510(k) Applications for Medical Device Product Code "FIN"
(Tank, Holding, Dialysis)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K141213	AMERIWATER	AMERIWATER OZONE DISINFECTION SYSTEM	12/10/2014
K051031	AMERIWATER	AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS	01/06/2006
K992793	BETTER WATER, INC.	SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM	11/16/1999
K961416	DIAL MEDICAL SUPPLY	DIALYSIS MIXING & HOLDING TANK	08/21/1996
K060333	DIALYSIS SERVICES, INC.	DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM	09/08/2006
K030366	DIALYSIS SYSTEMS, INC.	BICARD MIXING SYSTEM	04/19/2004
K970674	G.E.M. WATER SYSTEMS	G.E.M. WATER SYSTEMS, INTERNATIONAL	11/19/1997
K112427	ISOPURE CORP.	BICARB MIXING AND DISTRIBUTION SYSTEM	01/26/2012
K003560	MAR COR SERVICES, INC.	MAR COR SERVICES BICARB SYSTEM	06/08/2001
K033118	MEDICAL SOLUTIONS INTERNATIONAL	BIPRO MODEL SDS-CB200	06/28/2004
K023011	OSMONICS MEDICAL SYSTEMS	OSMONICS SOLUTION DELIVERY SYSTEM	06/26/2003
K993058	PURE WATER, INC.	PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL	01/24/2000
K993272	PURE WATER, INC.	PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM	04/10/2000
K140984	TANGO3, LLC	TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM	01/12/2015
K093641	TANGO3, LLC	TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM	12/08/2010
K031502	USFILTER	USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM	08/27/2004