|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
fresenius naturalyte granuflo dry acid concentrate 10xx series, 24xx series, 30xx series
|
FRESENIUS MEDICAL CARE
|
K030497 |
05/20/2003
|
fresenius naturalyte liquid acid concentrate, 9000, 6000 and 4000 series
|
FRESENIUS MEDICAL CARE NORTH AMERICA
|
K070177 |
03/29/2007
|
fresenius naturalyte sodium bicarbonate liquid concentrate, model 08-4000-lb
|
FRESENIUS MEDICAL CARE NORTH AMERICA
|
K071387 |
06/15/2007
|
fresenius 2008t hemodialysis machine model 190573
|
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
|
K101715 |
12/21/2010
|
2008k@home hemodialysis machine
|
FRESENIUS MEDICAL CARE NORTH AMERICA
|
K124035 |
07/03/2013
|
fresenius 2008 hemodiaysis machine with bibag system
|
FRESENIUS MEDICAL CARE, NORTH AMERICA
|
K120017 |
02/02/2012
|
fresenius 2008t hemodialysis machine with bibag system
|
FRESENIUS MEDICAL CARE, NORTH AMERICA
|
K121341 |
12/06/2012
|
fresenius dry acid dissolution units
|
FRESENIUS MEDICAL CARE NORTH AMERICA
|
K131611 |
08/29/2013
|
bibag
|
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
|
K162716 |
05/18/2017
|
citrasate dry acid concentrate, granuflo dry acid concentrate
|
Fresenius Medical Care Renal Therapies Group, LLC
|
K192209 |
05/08/2020
|