Home / Device Classification / FIN

FIN — Tank, Holding, Dialysis Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K140984tango3TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMJanuary 12, 2015
K141213ameriwaterAMERIWATER OZONE DISINFECTION SYSTEMDecember 10, 2014
K112427isopureBICARB MIXING AND DISTRIBUTION SYSTEMJanuary 26, 2012
K093641tango3TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMDecember 8, 2010
K060333dialysis servicesDIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEMSeptember 8, 2006
K051031ameriwaterAMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISJanuary 6, 2006
K031502usfilterUSFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMAugust 27, 2004
K033118medical solutions internationalBIPRO MODEL SDS-CB200June 28, 2004
K030366dialysis systemsBICARD MIXING SYSTEMApril 19, 2004
K023011osmonics medical systemsOSMONICS SOLUTION DELIVERY SYSTEMJune 26, 2003
K003560mar cor servicesMAR COR SERVICES BICARB SYSTEMJune 8, 2001
K993272pure waterPURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEMApril 10, 2000
K993058pure waterPURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE January 24, 2000
K992793better waterSODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEMNovember 16, 1999
K970674g.e.m. water systemsG.E.M. WATER SYSTEMS, INTERNATIONALNovember 19, 1997
K961416dial medical supplyDIALYSIS MIXING & HOLDING TANKAugust 21, 1996
K883408national medical care, medical products divNATURALYTE MIXEROctober 31, 1988
K873166specialty dialysis servicesBCM DRY PACK BICARBONATE MIXERDecember 30, 1987