Panels › Gastroenterology, Urology › Product code FIN · Class 2
Tank, Holding, Dialysis
Regulation 876.5820
0510(k)s in 12 months (18 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in FIN
| Company | 510(k)s | Recalls |
|---|---|---|
| Isopure, Corp. | 1 | 2 |
| Tango3, LLC | 2 | 1 |
| Ameriwater | 2 | 0 |
| Pure Water, Inc. | 2 | 0 |
| Better Water, Inc. | 1 | 0 |
| Dial Medical Supply | 1 | 0 |
| Dialysis Services, Inc. | 1 | 0 |
| Dialysis Systems, Inc. | 1 | 0 |
| G.E.M. Water Systems | 1 | 0 |
| Hill-Rom, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2015 | K140984 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM Tango3, LLC | FIN |
| Dec 10, 2014 | K141213 | AMERIWATER OZONE DISINFECTION SYSTEM Ameriwater | FIN |
| Jan 26, 2012 | K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM Isopure, Corp. | FIN |
| Dec 8, 2010 | K093641 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM Tango3, LLC | FIN |
| Sep 8, 2006 | K060333 | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM Dialysis Services, Inc. | FIN |
| Jan 6, 2006 | K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS Ameriwater | FIN |
| Aug 27, 2004 | K031502 | USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM Usfilter | FIN |
| Jun 28, 2004 | K033118 | BIPRO MODEL SDS-CB200 Medical Solutions International | FIN |
| Apr 19, 2004 | K030366 | BICARD MIXING SYSTEM Dialysis Systems, Inc. | FIN |
| Jun 26, 2003 | K023011 | OSMONICS SOLUTION DELIVERY SYSTEM Osmonics Medical Systems | FIN |
| Jun 8, 2001 | K003560 | MAR COR SERVICES BICARB SYSTEM Mar Cor Services, Inc. | FIN |
| Apr 10, 2000 | K993272 | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM Pure Water, Inc. | FIN |
| Jan 24, 2000 | K993058 | PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL Pure Water, Inc. | FIN |
| Nov 16, 1999 | K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM Better Water, Inc. | FIN |
| Nov 19, 1997 | K970674 | G.E.M. WATER SYSTEMS, INTERNATIONAL G.E.M. Water Systems | FIN |
| Aug 21, 1996 | K961416 | DIALYSIS MIXING & HOLDING TANK Dial Medical Supply | FIN |
| Oct 31, 1988 | K883408 | NATURALYTE MIXER National Medical Care, Medical Products Div., Inc. | FIN |
| Dec 30, 1987 | K873166 | BCM DRY PACK BICARBONATE MIXER Specialty Dialysis Services | FIN |
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