|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
exalis, software version 1.15
|
GAMBRO, INC.
|
K083158 |
06/05/2009
|
phoenix hemodialysis delivery system, version 3.35
|
GAMBRO, INC.
|
K070643 |
11/02/2007
|
prisma m60/m100 sets
|
GAMBRO, INC.
|
K032431 |
09/15/2003
|
gambro lundia ic-6h parallel plate dialyzer
|
GAMBRO, INC.
|
K900918 |
07/16/1990
|
gambro polyflux 130 and 160 hemodialyzer
|
GAMBRO, INC.
|
K871108 |
05/15/1987
|
gambro fiber hemofilters fh 22/66 dispos tube sets
|
GAMBRO, INC.
|
K860938 |
04/07/1986
|
gambro blood concentrator sets 16,60,200
|
GAMBRO, INC.
|
K854309 |
12/13/1985
|
blood concentrator 140
|
GAMBRO, INC.
|
K840543 |
03/23/1984
|
hemofiltration system
|
GAMBRO, INC.
|
K831784 |
02/04/1984
|
ultrafiltration monitor ufm-10-2
|
GAMBRO, INC.
|
K830596 |
04/27/1983
|
|