Product code FIN— Gastroenterology, Urology
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- Classification name
- Tank, Holding, Dialysis
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code FIN
FDA has cleared devices under product code FIN between 1987 and 2015, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2014
- 2012
- 2010
- 2006
- 2004
- 2003
- 2001
- 2000
- 1999
- 1997
- 1996
- 1988
- 1987
Top applicants under product code FIN
Recent clearances under product code FIN
- K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K141213 — AMERIWATER OZONE DISINFECTION SYSTEM
- K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM
- K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
- K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
- K031502 — USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
- K033118 — BIPRO MODEL SDS-CB200
- K030366 — BICARD MIXING SYSTEM
- K023011 — OSMONICS SOLUTION DELIVERY SYSTEM
- K003560 — MAR COR SERVICES BICARB SYSTEM
- K993272 — PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
- K993058 — PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
- K992793 — SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
- K970674 — G.E.M. WATER SYSTEMS, INTERNATIONAL
- K961416 — DIALYSIS MIXING & HOLDING TANK
- K883408 — NATURALYTE MIXER
- K873166 — BCM DRY PACK BICARBONATE MIXER
Data sourced from openFDA. This site is unofficial and independent of the FDA.