Device Classification Name |
controller, infusion, intravascular, electronic
|
510(k) Number |
K851058 |
Device Name |
DOSI FLOW |
Applicant |
LEVENTON, S.A. |
POLIGONO CAN SUYER, 11 |
SANT ANDREU DE LA BARCA |
BARCELONA,
ES
08740
|
|
Applicant Contact |
JUAN ALFONSO |
Correspondent |
LEVENTON, S.A. |
POLIGONO CAN SUYER, 11 |
SANT ANDREU DE LA BARCA |
BARCELONA,
ES
08740
|
|
Correspondent Contact |
JUAN ALFONSO |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/14/1985 |
Decision Date | 04/29/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|