Device Classification Name |
hemodialysis system for home use
|
510(k) Number |
K070049 |
Device Name |
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. |
WALTHAM,
MA
02451 -1457
|
|
Applicant Contact |
JANET C KAY |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. |
WALTHAM,
MA
02451 -1457
|
|
Correspondent Contact |
JANET C KAY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/2007 |
Decision Date | 02/03/2011 |
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
|
Recalls |
CDRH Recalls
|