FDA Product Code
FDA Product Code FIN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140984 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | Tango3, LLC | 2015-01-12 | Traditional | PDF ↗ |
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | Ameriwater | 2014-12-10 | Traditional | PDF ↗ |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | Isopure, Corp. | 2012-01-26 | Special | PDF ↗ |
| K093641 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | Tango3, LLC | 2010-12-08 | Traditional | PDF ↗ |
| K060333 | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM | Dialysis Services, Inc. | 2006-09-08 | Traditional | PDF ↗ |
| K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | Ameriwater | 2006-01-06 | Traditional | PDF ↗ |
| K031502 | USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM | Usfilter | 2004-08-27 | Traditional | PDF ↗ |
| K033118 | BIPRO MODEL SDS-CB200 | Medical Solutions International | 2004-06-28 | Traditional | PDF ↗ |
| K030366 | BICARD MIXING SYSTEM | Dialysis Systems, Inc. | 2004-04-19 | Traditional | PDF ↗ |
| K023011 | OSMONICS SOLUTION DELIVERY SYSTEM | Osmonics Medical Systems | 2003-06-26 | Traditional | PDF ↗ |
| K003560 | MAR COR SERVICES BICARB SYSTEM | Mar Cor Services, Inc. | 2001-06-08 | Traditional | PDF ↗ |
| K993272 | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM | Pure Water, Inc. | 2000-04-10 | Traditional | PDF ↗ |
| K993058 | PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL | Pure Water, Inc. | 2000-01-24 | Traditional | PDF ↗ |
| K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM | Better Water, Inc. | 1999-11-16 | Traditional | PDF ↗ |
| K970674 | G.E.M. WATER SYSTEMS, INTERNATIONAL | G.E.M. Water Systems | 1997-11-19 | Traditional | PDF ↗ |
| K961416 | DIALYSIS MIXING & HOLDING TANK | Dial Medical Supply | 1996-08-21 | Traditional | PDF ↗ |
| K883408 | NATURALYTE MIXER | National Medical Care, Medical Products Div., Inc. | 1988-10-31 | Traditional | PDF ↗ |
| K873166 | BCM DRY PACK BICARBONATE MIXER | Specialty Dialysis Services | 1987-12-30 | Traditional | PDF ↗ |
Product code FIN · Class II · Gastroenterology, Urology. Data: openFDA.