FIN — Tank, Holding, Dialysis Class II
FDA product code FIN covers "Tank, Holding, Dialysis", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIN
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140984 | tango3 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | January 12, 2015 |
| K141213 | ameriwater | AMERIWATER OZONE DISINFECTION SYSTEM | December 10, 2014 |
| K112427 | isopure | BICARB MIXING AND DISTRIBUTION SYSTEM | January 26, 2012 |
| K093641 | tango3 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | December 8, 2010 |
| K060333 | dialysis services | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM | September 8, 2006 |
| K051031 | ameriwater | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | January 6, 2006 |
| K031502 | usfilter | USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM | August 27, 2004 |
| K033118 | medical solutions international | BIPRO MODEL SDS-CB200 | June 28, 2004 |
| K030366 | dialysis systems | BICARD MIXING SYSTEM | April 19, 2004 |
| K023011 | osmonics medical systems | OSMONICS SOLUTION DELIVERY SYSTEM | June 26, 2003 |
| K003560 | mar cor services | MAR COR SERVICES BICARB SYSTEM | June 8, 2001 |
| K993272 | pure water | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM | April 10, 2000 |
| K993058 | pure water | PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE | January 24, 2000 |
| K992793 | better water | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM | November 16, 1999 |
| K970674 | g.e.m. water systems | G.E.M. WATER SYSTEMS, INTERNATIONAL | November 19, 1997 |
| K961416 | dial medical supply | DIALYSIS MIXING & HOLDING TANK | August 21, 1996 |
| K883408 | national medical care, medical products div | NATURALYTE MIXER | October 31, 1988 |
| K873166 | specialty dialysis services | BCM DRY PACK BICARBONATE MIXER | December 30, 1987 |