Device Classification Name |
accessories, pump, infusion
|
510(k) Number |
K101806 |
Device Name |
AIDERA DIASEND SYSTEM |
Applicant |
AIDERA AB |
MEDICINAREGATAN 8A |
goteborg,
SE
se 413 46
|
|
Applicant Contact |
anders sonesson |
Correspondent |
AIDERA AB |
MEDICINAREGATAN 8A |
goteborg,
SE
se 413 46
|
|
Correspondent Contact |
anders sonesson |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/28/2010 |
Decision Date | 12/07/2010 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|