Device Classification Name |
hemodialysis system for home use
|
510(k) Number |
K121421 |
Device Name |
FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 WINTER STREET |
WALTHAM,
MA
01854 -1457
|
|
Applicant Contact |
COLLEEN DURRAN |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 WINTER STREET |
WALTHAM,
MA
01854 -1457
|
|
Correspondent Contact |
COLLEEN DURRAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/14/2012 |
Decision Date | 01/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|