Device Classification Name |
Hemodialysis System For Home Use
|
510(k) Number |
K124035 |
Device Name |
2008K@HOME HEMODIALYSIS MACHINE |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451 -1457
|
|
Applicant Contact |
DENISE OPPERMANN |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451 -1457
|
|
Correspondent Contact |
DENISE OPPERMANN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/28/2012 |
Decision Date | 07/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|