FIN · Class II · 21 CFR 876.5820

FDA Product Code FIN: Tank, Holding, Dialysis

Leading manufacturers include Pure Water, Inc., Ameriwater and Tango3, LLC.

18
Total
18
Cleared
233d
Avg days
1987
Since

FDA 510(k) Cleared Tank, Holding, Dialysis Devices (Product Code FIN)

18 devices
1–18 of 18
Cleared Jan 12, 2015
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K140984
Tango3, LLC
Gastroenterology & Urology · 271d
Cleared Dec 10, 2014
AMERIWATER OZONE DISINFECTION SYSTEM
K141213
Ameriwater
Gastroenterology & Urology · 212d
Cleared Jan 26, 2012
BICARB MIXING AND DISTRIBUTION SYSTEM
K112427
Isopure, Corp.
Gastroenterology & Urology · 156d
Cleared Dec 08, 2010
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K093641
Tango3, LLC
Gastroenterology & Urology · 379d
Cleared Sep 08, 2006
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333
Dialysis Services, Inc.
Gastroenterology & Urology · 211d
Cleared Jan 06, 2006
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031
Ameriwater
Gastroenterology & Urology · 259d
Cleared Aug 27, 2004
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
K031502
Usfilter
Gastroenterology & Urology · 472d
Cleared Jun 28, 2004
BIPRO MODEL SDS-CB200
K033118
Medical Solutions International
Gastroenterology & Urology · 272d
Cleared Apr 19, 2004
BICARD MIXING SYSTEM
K030366
Dialysis Systems, Inc.
Gastroenterology & Urology · 440d
Cleared Jun 26, 2003
OSMONICS SOLUTION DELIVERY SYSTEM
K023011
Osmonics Medical Systems
Gastroenterology & Urology · 290d
Cleared Jun 08, 2001
MAR COR SERVICES BICARB SYSTEM
K003560
Mar Cor Services, Inc.
Gastroenterology & Urology · 203d
Cleared Apr 10, 2000
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272
Pure Water, Inc.
Gastroenterology & Urology · 193d
Cleared Jan 24, 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
K993058
Pure Water, Inc.
Gastroenterology & Urology · 133d
Cleared Nov 16, 1999
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
K992793
Better Water, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 19, 1997
G.E.M. WATER SYSTEMS, INTERNATIONAL
K970674
G.E.M. Water Systems
Gastroenterology & Urology · 268d
Cleared Aug 21, 1996
DIALYSIS MIXING & HOLDING TANK
K961416
Dial Medical Supply
Gastroenterology & Urology · 131d
Cleared Oct 31, 1988
NATURALYTE MIXER
K883408
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 81d
Cleared Dec 30, 1987
BCM DRY PACK BICARBONATE MIXER
K873166
Specialty Dialysis Services
Gastroenterology & Urology · 141d

About Product Code FIN - Regulatory Context