FDA.reportPublic FDA data

510(k) K873166

Device
BCM DRY PACK BICARBONATE MIXER
Applicant
SPECIALTY DIALYSIS SERVICES
510(k) number
K873166
Product code
FIN  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-30
Date received
1987-08-11
Regulation
876.5820
Classification name
Tank, Holding, Dialysis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRIAN MEAD
Address
1059 W. La Jolla Dr. Tempe AZ US 85282 85282

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FIN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140984TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLC2015-01-12
K141213AMERIWATER OZONE DISINFECTION SYSTEMAmeriwater2014-12-10
K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.2012-01-26
K093641TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLC2010-12-08
K060333DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEMDialysis Services, Inc.2006-09-08
K051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISAmeriwater2006-01-06
K031502USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMUsfilter2004-08-27
K033118BIPRO MODEL SDS-CB200Medical Solutions International2004-06-28
K030366BICARD MIXING SYSTEMDialysis Systems, Inc.2004-04-19
K023011OSMONICS SOLUTION DELIVERY SYSTEMOsmonics Medical Systems2003-06-26
K003560MAR COR SERVICES BICARB SYSTEMMar Cor Services, Inc.2001-06-08
K993272PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEMPure Water, Inc.2000-04-10
K993058PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILLPure Water, Inc.2000-01-24
K992793SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEMBetter Water, Inc.1999-11-16
K970674G.E.M. WATER SYSTEMS, INTERNATIONALG.E.M. Water Systems1997-11-19

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases